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A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Primary Purpose

Influenza, Human

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
oseltamivir
placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
  • Immunocompromised participants with primary or secondary immunodeficiency
  • Symptoms suggestive of influenza-like illness
  • Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

Exclusion Criteria:

  • Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
  • Antiviral treatment for influenza in 2 weeks prior to randomization
  • Severe hepatic impairment
  • Any current renal replacement therapy
  • Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
  • Participation in a study with an investigational drug from 4 weeks prior to study start until study end

Sites / Locations

  • Uni of Alabama At Birmingham; Division of Nephrology
  • University of Alabama at Birmingham; Pediatric Nephrology
  • Pacific Oaks Medical Group
  • Providence Clinical Research
  • AIDS Research Alliance
  • UCLA Medical center Medicine/Nephrology
  • University of California Davis Health System
  • CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi
  • University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan
  • New England Research Associates
  • Christiana Care Health System
  • Omega Research Consultants
  • All Children'S Hospital; Pediatric Blood & Marrow Transplant Program
  • Kendall South Medical Center Inc.
  • Vita Research Solutions, Inc
  • University of South Florida
  • Piedmont Hospital; Transplant Services
  • EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
  • Medical College of Georgia; Medicine/ Nephrology
  • Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine
  • Rush Uni Medical Center; Medicine/ Section of Infectious Diseases
  • University of Chicago; Infectious Disease
  • Tulane University Medical Center
  • University of Maryland School of Medicine
  • Brigham & Women'S Hospital
  • Western New England Renal & Transplant Associates, P.C.
  • Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease
  • Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
  • Henry Ford Health System; Gastroenterology
  • Wayne State University School of Medicine
  • Beals Institute PC
  • Washington University; Wash Uni. Sch. Of Med
  • Our Lady of Lourdes Medical Center; Transplant Dept
  • Hackensack University Medical Center
  • Long Island Jewish/North Shore Hospital
  • Mount Sinai Medical Center; Division of Liver Diseases
  • DJL Clinical Research PLLC
  • Novant Health Pulmonary and Critical Care
  • Duke University Health Systems
  • Wake Forest University Baptist Medical Center
  • Uni of Cincinnati Medical Center; Nephrology & Hypertension
  • Cleveland Clinic Foundation; Infectious Disease
  • Toledo Hospital
  • Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Drexel University; College of Medicine
  • Uni of Pennsylvania; Infectious Diseases
  • University of Pennsylvania Health System
  • Children'S Hospital of Pittsburgh; Infectious Disease
  • Medical University of South Carolina; Pediatric Cardiology
  • Children'S Medical Center of Dallas
  • Baylor University Medical Center Transplant Administration
  • UT Southwestern Medical Center; Pediatrics Dept.
  • Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation
  • The Methodist Hospital
  • M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health
  • Texas Tech University Health Sciences Center; Department of Urology
  • University of Texas Health Science Center Transplant center
  • Scott and White Division of Nephrology Dept of Medicine
  • University of Utah Health Science Center Gastroenterology
  • Hospital General de Agudos Juan Antonio Fernandez; infectología
  • Instituto Medico Platense
  • Instituto Medico Especializado Alexander Fleming
  • Hospital General de Agudos Dr. Ignacio Pirovano
  • Hospital Italiano de La Plata
  • Hospital de Niños Dr. Orlando Alassia
  • Onze Lieve Vrouwziekenhuis Aalst
  • UZ Brussel
  • Institut Jules Bordet
  • Hospital Erasme; Neurologie
  • Fiocruz - Fundação Oswaldo Cruz
  • Hospital Alemao Oswaldo Cruz; Oncologia
  • Iop - Graacc - Unifesp
  • Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
  • Hospital das Clinicas - FMUSP
  • UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis
  • UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases
  • Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital
  • Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations
  • Uni of Manitoba; Faculty of Medicine
  • St Paul'S
  • Hospital Luis Calvo Mackenna; Unidad de Investigacion
  • Hospital Dr. Sotero del Rio
  • Centro de Investigaciones Clinicas Viña del Mar
  • Infectologos Asociados
  • Simedics Ips
  • Centro de Investigaciones Clinicas S.A.S
  • Fundacion Cardiovascular de Colombia - Instituto del Corazón
  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
  • Fakultni Nemocnice; Hemato-Oncology
  • Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF
  • The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf
  • KASMED, s.r.o.; Alergologie a klinicka imunologie
  • Revmatologicka Ambulance-Terezin
  • Revmatologicka ambulance
  • West Tallinn Central Hospital; Nephrology
  • North Estonia medical Centre; Hematology
  • Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology
  • Tartu Uni Hospital; Hematology - Oncology Clinic
  • Tartu University Hospital; Department of Infectious Diseases
  • Centre Hospitalier de la Croix Rousse
  • Hopital Robert Debre; Pediatric Hematology Dept
  • Hopital Saint Louis; Service de Nephrologie - Transplantation
  • Hopital Europeen Georges Pompidou; Service de Nephrologie
  • Hopital Rangueil; Nephrologie
  • CHRU Bretonneau
  • Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
  • Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie
  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
  • Universitätsklinikum Hamburg-Eppendorf
  • UNI-Klinikum Heidelberg Chirurgische Klinik
  • Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie
  • Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV
  • Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
  • Clinica Familiar Luis Angel Garcia
  • CERICAP
  • Centro de Investigaciones Pediatricas
  • Hospital Roosevelt Guatemala; Clinica de Infecciosas
  • Unidad Nacional de Oncologia Pediatrica
  • Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.
  • Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;
  • Petz Aladar Megyei Korhaz; Hematologia
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
  • Pecsi Tudomanyegyetem
  • University of Szeged; Transplantation Department
  • Fejer Megyei Szent Gyorgy Korhaz
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
  • Rambam Health Care Campus; Hematology
  • Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.
  • Rabin MC- Belinson campus
  • Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation
  • Rabin Medical Center; Liver Inst.
  • Chaim Sheba Medical Center; Hematology BMT & CBB
  • Sourasky MC; Transplant Unit
  • Chaim Sheba MC; Pediatric Hematology Oncology
  • Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali
  • POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
  • I.N.M.I. L. Spallanzani IRCCS
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive
  • ASST DI MONZA; Divisione Malattie Infettive
  • Fondazione IRCCS Policlinico San Matteo
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi
  • Latvia Transplantation Center P. Stradina Hospital; Transplantation
  • Children's Clinical University Hospital
  • Kaunas Clinics Public Institution; Clinic of Nephrology
  • Klaipeda University Hospital; Public Institution
  • Siauliai Republican Hospital Public Institution
  • Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
  • Vilnius University Hospital Santariskiu Clinic
  • Republican Tuberculosis and Infectious Diseases University H
  • Phylaxis Clinical Research S de RL de CV
  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7
  • Centro de Investigacion Clínica GRAMEL S.C
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia
  • INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
  • Hospital Universitario de Monterrey; Infectologia
  • Hospital de Especialidades del Centro Medico Puerta de Hierr
  • Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku
  • NZOZ Vitamed
  • Uniwersyteckie Centrum Kliniczne
  • SPZOZ Szpital Uniw W Krakowie
  • SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM
  • SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
  • Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology
  • Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
  • SP Szpital Kliniczny Nr 1 we Wroclawiu
  • ALL-MED Specjalistyczna Opieka Medyczna
  • Institutul de Urologie Si Transplant Renal Fundeni
  • Josha Research
  • Londisizwe Research Centre
  • Sebastian Peter
  • Dr V Naidoo Private Practice
  • Govind U
  • Soweto CTC - Dr Phoshoko site
  • Soweto CTC - Dr Mushwana site
  • Newtown Clinical Research
  • Mzansi Ethical Research Centre
  • Be Part Yoluntu Centre
  • Global Clinical Trials Port Elizabeth
  • Kalafong Hospital; Pathology
  • Emmed Research
  • Synexus Clinical Research Centres SA Stanza Bopape
  • Soweto Clinical Trial Centre
  • Tygerberg Hospital Pediatrics and Child Health
  • Welkom Clinical Trial Centre
  • Hospital Universitari de Bellvitge; Servicio de Nefrologia
  • Hospital Clinico Universitario de Santiago
  • Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital General Universitario Gregorio Marañon
  • Hospital Infantil Universitario Nino Jesus
  • Hospital Clinico San Carlos; Servicio de Nefrologia
  • Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas
  • Hospital Universitario 12 de Octubre; HIV Unit
  • Hospital Universitario 12 de Octubre; Servicio de Pediatria
  • Hospital Universitario La Paz; Hepatología y Trasplantes
  • Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit
  • Universitätsspital Zürich; Klinik für Nephrologie
  • Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT
  • Institute of Nephrology AMS; Dept of Nephrology & dialysis
  • Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed
  • Zaporozhye State Medical University; Dept of Transplantology
  • University Hospitals Bristol NHS Foundation Trust
  • Manchester Royal Infirmary; Renal Transplant Unit
  • Nottingham City Hospital; Transplant Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional dose

Double dose

Arm Description

Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.

Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.
Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)
The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.

Secondary Outcome Measures

Time to Resolution (TTR) of All Clinical Influenza Symptoms
TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.
Total Symptom Score Area Under the Efficacy Curve (AUE)
The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.
Time to Resolution of Fever
Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.
Change From Baseline in Viral Load Assessed by Culture
Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time to Cessation of Viral Shedding by Cell Culture
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time to Cessation of Viral Shedding by RT-PCR
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants With Persistent Viral Shedding
Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants Who Developed Secondary Illness
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants Who Initiated Antibiotic Treatment
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.
Percentage of Participants Hospitalized
Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
Duration of Hospitalization
Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults
Reported here are oseltamivir Cmax data for adults >/= 18 years.
Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults
Reported here are oseltamivir Ctrough data for adults >/= 18 years.
Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults
AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults
Reported here are oseltamivir tmax data for adults >/= 18 years.
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults
Reported here are oseltamivir ke data for adults >/= 18 years.
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults
Reported here are oseltamivir CL/F data for adults >/= 18 years.
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults
Reported here are oseltamivir Vc/F data for adults >/= 18 years.
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.
Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults
Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults
Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.

Full Information

First Posted
October 16, 2007
Last Updated
June 15, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00545532
Brief Title
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Official Title
A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 4, 2008 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional dose
Arm Type
Experimental
Arm Description
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
Arm Title
Double dose
Arm Type
Experimental
Arm Description
Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
Intervention Type
Drug
Intervention Name(s)
oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo matched to oseltamivir po twice daily for 10 days
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline up to Day 40
Title
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Description
Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.
Time Frame
Baseline up to Day 40
Title
Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)
Description
The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.
Time Frame
Baseline up to Day 40
Secondary Outcome Measure Information:
Title
Time to Resolution (TTR) of All Clinical Influenza Symptoms
Description
TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.
Time Frame
Baseline up to Day 40
Title
Total Symptom Score Area Under the Efficacy Curve (AUE)
Description
The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.
Time Frame
Baseline up to Day 40
Title
Time to Resolution of Fever
Description
Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.
Time Frame
Baseline up to Day 40
Title
Change From Baseline in Viral Load Assessed by Culture
Description
Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
Title
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
Description
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
Title
Time to Cessation of Viral Shedding by Cell Culture
Description
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Description
Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
Title
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
Description
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.
Title
Time to Cessation of Viral Shedding by RT-PCR
Description
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Percentage of Participants With Persistent Viral Shedding
Description
Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline to Day 11 (EOT)
Title
Percentage of Participants Who Developed Secondary Illness
Description
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Percentage of Participants Who Initiated Antibiotic Treatment
Description
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Percentage of Participants Hospitalized
Description
Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Duration of Hospitalization
Description
Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
Time Frame
Baseline up to Day 40
Title
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults
Description
Reported here are oseltamivir Cmax data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults
Description
Reported here are oseltamivir Ctrough data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults
Description
AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults
Description
Reported here are oseltamivir tmax data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults
Description
Reported here are oseltamivir ke data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults
Description
Reported here are oseltamivir CL/F data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults
Description
Reported here are oseltamivir Vc/F data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults
Description
Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults
Description
Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
Description
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
Description
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Description
Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose
Title
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Description
Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Time Frame
Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose Immunocompromised participants with primary or secondary immunodeficiency Symptoms suggestive of influenza-like illness Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding Exclusion Criteria: Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization Antiviral treatment for influenza in 2 weeks prior to randomization Severe hepatic impairment Any current renal replacement therapy Any gastrointestinal disorders which may interfere with the absorption of oseltamivir Participation in a study with an investigational drug from 4 weeks prior to study start until study end
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Uni of Alabama At Birmingham; Division of Nephrology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham; Pediatric Nephrology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pacific Oaks Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
AIDS Research Alliance
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
UCLA Medical center Medicine/Nephrology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
New England Research Associates
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
All Children'S Hospital; Pediatric Blood & Marrow Transplant Program
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Kendall South Medical Center Inc.
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Vita Research Solutions, Inc
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont Hospital; Transplant Services
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical College of Georgia; Medicine/ Nephrology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Uni Medical Center; Medicine/ Section of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago; Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60655
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham & Women'S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Western New England Renal & Transplant Associates, P.C.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0378
Country
United States
Facility Name
Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System; Gastroenterology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48210
Country
United States
Facility Name
Beals Institute PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Our Lady of Lourdes Medical Center; Transplant Dept
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Long Island Jewish/North Shore Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai Medical Center; Division of Liver Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
DJL Clinical Research PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Novant Health Pulmonary and Critical Care
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Duke University Health Systems
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Uni of Cincinnati Medical Center; Nephrology & Hypertension
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Foundation; Infectious Disease
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4481
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University; College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Uni of Pennsylvania; Infectious Diseases
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children'S Hospital of Pittsburgh; Infectious Disease
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina; Pediatric Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Children'S Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center Transplant Administration
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center; Pediatrics Dept.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation
City
Dallas
State/Province
Texas
ZIP/Postal Code
TX 75246
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Sciences Center; Department of Urology
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
University of Texas Health Science Center Transplant center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott and White Division of Nephrology Dept of Medicine
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Utah Health Science Center Gastroenterology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Hospital General de Agudos Juan Antonio Fernandez; infectología
City
Buenos Aires
ZIP/Postal Code
1202
Country
Argentina
Facility Name
Instituto Medico Platense
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital General de Agudos Dr. Ignacio Pirovano
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
1725
Country
Argentina
Facility Name
Hospital de Niños Dr. Orlando Alassia
City
Santa Fe
ZIP/Postal Code
S3000CII
Country
Argentina
Facility Name
Onze Lieve Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hospital Erasme; Neurologie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Fiocruz - Fundação Oswaldo Cruz
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Iop - Graacc - Unifesp
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Uni of Manitoba; Faculty of Medicine
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 6518
Country
Canada
Facility Name
St Paul'S
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 0Z9
Country
Canada
Facility Name
Hospital Luis Calvo Mackenna; Unidad de Investigacion
City
Santiago
ZIP/Postal Code
7500539
Country
Chile
Facility Name
Hospital Dr. Sotero del Rio
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Centro de Investigaciones Clinicas Viña del Mar
City
Viña Del Mar Valparaiso
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Infectologos Asociados
City
Barranquilla
Country
Colombia
Facility Name
Simedics Ips
City
Bogota
Country
Colombia
Facility Name
Centro de Investigaciones Clinicas S.A.S
City
Cali
Country
Colombia
Facility Name
Fundacion Cardiovascular de Colombia - Instituto del Corazón
City
Floridablanca
Country
Colombia
Facility Name
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Nemocnice; Hemato-Oncology
City
Plzen
ZIP/Postal Code
300 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf
City
Praha
ZIP/Postal Code
12820
Country
Czechia
Facility Name
KASMED, s.r.o.; Alergologie a klinicka imunologie
City
Tabor
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Revmatologicka Ambulance-Terezin
City
Terezin
ZIP/Postal Code
411 55
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
West Tallinn Central Hospital; Nephrology
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia medical Centre; Hematology
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Tartu Uni Hospital; Hematology - Oncology Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Tartu University Hospital; Department of Infectious Diseases
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Centre Hospitalier de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hopital Robert Debre; Pediatric Hematology Dept
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hopital Saint Louis; Service de Nephrologie - Transplantation
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Europeen Georges Pompidou; Service de Nephrologie
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hopital Rangueil; Nephrologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
City
Aachen
ZIP/Postal Code
52057
Country
Germany
Facility Name
Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
UNI-Klinikum Heidelberg Chirurgische Klinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinica Familiar Luis Angel Garcia
City
Ciudad de Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
CERICAP
City
Ciudad de Guatemala
ZIP/Postal Code
01009
Country
Guatemala
Facility Name
Centro de Investigaciones Pediatricas
City
Guatemala City
ZIP/Postal Code
1015
Country
Guatemala
Facility Name
Hospital Roosevelt Guatemala; Clinica de Infecciosas
City
Guatemala City
Country
Guatemala
Facility Name
Unidad Nacional de Oncologia Pediatrica
City
Guatemala
Country
Guatemala
Facility Name
Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Korhaz; Hematologia
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
University of Szeged; Transplantation Department
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Rambam Health Care Campus; Hematology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin MC- Belinson campus
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Rabin Medical Center; Liver Inst.
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center; Hematology BMT & CBB
City
Ramat Gan
ZIP/Postal Code
52662
Country
Israel
Facility Name
Sourasky MC; Transplant Unit
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba MC; Pediatric Hematology Oncology
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
I.N.M.I. L. Spallanzani IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
RM 00149
Country
Italy
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25126
Country
Italy
Facility Name
ASST DI MONZA; Divisione Malattie Infettive
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi
City
Milano
State/Province
Molise
ZIP/Postal Code
20122
Country
Italy
Facility Name
Latvia Transplantation Center P. Stradina Hospital; Transplantation
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Children's Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Facility Name
Kaunas Clinics Public Institution; Clinic of Nephrology
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital; Public Institution
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Siauliai Republican Hospital Public Institution
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Republican Tuberculosis and Infectious Diseases University H
City
Vilnius
ZIP/Postal Code
8117
Country
Lithuania
Facility Name
Phylaxis Clinical Research S de RL de CV
City
Cuautitlan Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
ZIP/Postal Code
03720
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia
City
Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario de Monterrey; Infectologia
City
Monterrey
ZIP/Postal Code
64040
Country
Mexico
Facility Name
Hospital de Especialidades del Centro Medico Puerta de Hierr
City
Zapopan
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
SPZOZ Szpital Uniw W Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
Facility Name
Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
SP Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
ALL-MED Specjalistyczna Opieka Medyczna
City
Wroclaw
ZIP/Postal Code
50-445
Country
Poland
Facility Name
Institutul de Urologie Si Transplant Renal Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Londisizwe Research Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Sebastian Peter
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Dr V Naidoo Private Practice
City
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Govind U
City
Durban
ZIP/Postal Code
4096
Country
South Africa
Facility Name
Soweto CTC - Dr Phoshoko site
City
Johannesburg
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Soweto CTC - Dr Mushwana site
City
Johannesburg
ZIP/Postal Code
1983
Country
South Africa
Facility Name
Newtown Clinical Research
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Be Part Yoluntu Centre
City
Paarl
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Global Clinical Trials Port Elizabeth
City
Port Elizabeth
ZIP/Postal Code
6020
Country
South Africa
Facility Name
Kalafong Hospital; Pathology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Synexus Clinical Research Centres SA Stanza Bopape
City
Pretoria
ZIP/Postal Code
0112
Country
South Africa
Facility Name
Soweto Clinical Trial Centre
City
Soweto
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Tygerberg Hospital Pediatrics and Child Health
City
Tygerberg; Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Welkom Clinical Trial Centre
City
Welkom
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Hospital Universitari de Bellvitge; Servicio de Nefrologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; HIV Unit
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Pediatria
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Hepatología y Trasplantes
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Universitätsspital Zürich; Klinik für Nephrologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT
City
Kiev
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Institute of Nephrology AMS; Dept of Nephrology & dialysis
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed
City
Lugnansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Zaporozhye State Medical University; Dept of Transplantology
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Manchester Royal Infirmary; Renal Transplant Unit
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Nottingham City Hospital; Transplant Unit
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31667696
Citation
Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.
Results Reference
derived

Learn more about this trial

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

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