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A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

Primary Purpose

Cough, Sore Throat, Nasal Congestion

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peramivir+SOC
Placebo+SOC
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Influenza, Hospitalized, Antiviral, Flu

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥12 years of age, male or female.
  • Able to provide informed consent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines.
  • Subject must have at least one of the following clinical presentations at Screening:

    1. Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR
    2. Oxygen saturation <92%, OR
    3. Two out of the following three vital signs:

Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg

  • Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe).
  • Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe).
  • Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  • Either:

Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care.

OR

Presence of one or more of the following factors:

Age ≥60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy.

Current history of congestive heart failure or angina. Presence of diabetes mellitus, clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude >2000 ft above sea level will utilize different criteria for oxygen saturation).

History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine > 2.0 mg/dL or > 177 μmol/L.

  • Diagnosis of Influenza by satisfying one of the following:

    1. Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment.

      OR

    2. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution's local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season.

      Exclusion Criteria:

  • Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department).
  • Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days.
  • Blood platelet count of < 20 x 109/L at the time of the screening evaluation.
  • Serum bilirubin > 6 mg/dL or > 105 μmol/L at time of screening evaluation.
  • Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.
  • Congestive heart failure of NYHA Class III or Class IV functional status.
  • Serum creatinine > 5.0 mg/dL or > 500 μmol/L at time of screening evaluation.
  • Subjects who require peritoneal dialysis.
  • Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
  • Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding.
  • Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded.
  • Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
  • HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months.
  • Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or C not requiring treatment are not excluded.
  • Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
  • Previous treatment with intravenous or intramuscular peramivir.
  • Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation.
  • Subjects diagnosed with Cystic Fibrosis.
  • Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of screening evaluation.
  • Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Sites / Locations

  • Pulmonary Consultants PC Physicians Medical Group, Inc.
  • UC Davis Medical Center
  • Sharp Chula Vista Medical Center
  • Drogue Medical, LLC
  • Washington Hospital Center CAR
  • Florida Hospital
  • DeKalb Medical Center
  • Medical Arts Associates, Ltd.
  • Kentucky Lung Clinic
  • Beth Israel Deaconess Medical Center
  • Wayne State University - Hutzel Hospital
  • Wayne State University, Department of Emergency Medicine
  • William Beaumont Hospital
  • William Beaumont Hospital
  • Washington University School of Medicine
  • University of North Carolina at Chapel Hill AIDS Clinical Trials Unit
  • Remington-Davis, Inc.
  • Regional Infection Diseases Infusion Center Inc.
  • ID Clinical Research, LTD
  • Medical College Of Ohio
  • University of Virginia Health System
  • Carilion Infectious Disease
  • VA Medical Center - Salem
  • Hospital del Torax Dr. Antonio A. Cetrangolo
  • Hospital de Clinicas de Porto Alegre
  • DDPPDI - Ruse
  • Fifth MHAT-Sofia, AD
  • MHAT - Tokuda Hospital Sofia, AD
  • Military Medical Academy - MHAT
  • MHAT - Tokuda Hospital Sofia, AD
  • MHAT 'Dr. St. Cherkezov', AD
  • St. Joseph's Healthcare Hamilton
  • Hospital Clinico Regional Dr. Guillermo Grant Benavente
  • Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio
  • Fakultni nemocnice Brno
  • Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La
  • Universitaetsklinikum Regensburg
  • Fejer Megyei Szent Gyorgy Korhaz
  • Principal SMO Dr. Bugyi Istvan Korhaz Szentes
  • Fortis Escort Hospital
  • Apollo First Med Hospitals
  • Life Line Multispecialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peramivir+SOC

Placebo+SOC

Arm Description

Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Outcomes

Primary Outcome Measures

Time to Clinical Resolution (Kaplan-Meier Estimate)
Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).

Secondary Outcome Measures

Change (Reduction) in Influenza Virus Titer
The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.
Time to Alleviation of Clinical Symptoms of Influenza
Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.
Time to Resolution of Fever (Kaplan-Meier Estimate)
Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.
Time to Resumption of Usual Activities
Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.
Number of Subjects With ICU Admission
The number of subjects requiring ICU admission post-randomization was summarized by treatment group.
Duration of All ICU Admissions (Kaplan-Meier Estimate)
Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.

Full Information

First Posted
August 12, 2009
Last Updated
January 28, 2015
Sponsor
BioCryst Pharmaceuticals
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT00958776
Brief Title
A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Serious Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated for futility
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Sore Throat, Nasal Congestion, Headache, Fever, Seasonal Influenza
Keywords
Influenza, Hospitalized, Antiviral, Flu

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peramivir+SOC
Arm Type
Experimental
Arm Description
Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Arm Title
Placebo+SOC
Arm Type
Placebo Comparator
Arm Description
Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Intervention Type
Drug
Intervention Name(s)
Peramivir+SOC
Intervention Description
Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Intervention Type
Drug
Intervention Name(s)
Placebo+SOC
Intervention Description
Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Primary Outcome Measure Information:
Title
Time to Clinical Resolution (Kaplan-Meier Estimate)
Description
Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Change (Reduction) in Influenza Virus Titer
Description
The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.
Time Frame
Baseline and 24, 48, 108 hours
Title
Time to Alleviation of Clinical Symptoms of Influenza
Description
Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.
Time Frame
10 days
Title
Time to Resolution of Fever (Kaplan-Meier Estimate)
Description
Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.
Time Frame
10 days
Title
Time to Resumption of Usual Activities
Description
Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.
Time Frame
10 days
Title
Number of Subjects With ICU Admission
Description
The number of subjects requiring ICU admission post-randomization was summarized by treatment group.
Time Frame
10 days
Title
Duration of All ICU Admissions (Kaplan-Meier Estimate)
Description
Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
Time to Hospital Discharge
Description
Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.
Time Frame
10 days
Title
Incidence of Influenza-Related Complications
Description
Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.
Time Frame
10 days
Title
Number of Subjects Requiring More Than 5 Days of Study Drug
Description
Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.
Time Frame
10 days
Title
Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)
Description
Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.
Time Frame
28 days
Title
Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)
Description
Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.
Time Frame
Initial (baseline or post-baseline) and up to 10 days
Title
Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial
Description
Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.
Time Frame
Initial (baseline or post-baseline) and up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥12 years of age, male or female. Able to provide informed consent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines. Subject must have at least one of the following clinical presentations at Screening: Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR Oxygen saturation <92%, OR Two out of the following three vital signs: Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe). Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe). Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom. Either: Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care. OR Presence of one or more of the following factors: Age ≥60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy. Current history of congestive heart failure or angina. Presence of diabetes mellitus, clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude >2000 ft above sea level will utilize different criteria for oxygen saturation). History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine > 2.0 mg/dL or > 177 μmol/L. Diagnosis of Influenza by satisfying one of the following: Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment. OR Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution's local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season. Exclusion Criteria: Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department). Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days. Blood platelet count of < 20 x 109/L at the time of the screening evaluation. Serum bilirubin > 6 mg/dL or > 105 μmol/L at time of screening evaluation. Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation. Congestive heart failure of NYHA Class III or Class IV functional status. Serum creatinine > 5.0 mg/dL or > 500 μmol/L at time of screening evaluation. Subjects who require peritoneal dialysis. Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding. Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded. Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months. HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months. Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or C not requiring treatment are not excluded. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study. Previous treatment with intravenous or intramuscular peramivir. Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation. Subjects diagnosed with Cystic Fibrosis. Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of screening evaluation. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Facility Information:
City
La Mesa
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Modesto
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
Facility Name
Pulmonary Consultants PC Physicians Medical Group, Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Orange
State/Province
California
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sharp Chula Vista Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Drogue Medical, LLC
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Washington Hospital Center CAR
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Ft. Lauderdale
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Florida Hospital
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32790-2706
Country
United States
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Medical Arts Associates, Ltd.
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Kentucky Lung Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
City
Natchitoches
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Annapolis
State/Province
Maryland
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University - Hutzel Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State University, Department of Emergency Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Manhasset
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
Facility Name
University of North Carolina at Chapel Hill AIDS Clinical Trials Unit
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
Regional Infection Diseases Infusion Center Inc.
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
ID Clinical Research, LTD
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Medical College Of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
East Providence
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion Infectious Disease
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
VA Medical Center - Salem
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Hospital del Torax Dr. Antonio A. Cetrangolo
City
Buenos Aires
ZIP/Postal Code
1638
Country
Argentina
City
Buenos Aires
Country
Argentina
City
Caba
Country
Argentina
City
Cordoba
Country
Argentina
City
Mendoza
Country
Argentina
City
Merlo
Country
Argentina
City
Rosario
Country
Argentina
City
Santa Fe
Country
Argentina
City
Vicente Lopez
Country
Argentina
City
Bruxelles
Country
Belgium
City
Liege
Country
Belgium
City
Mons
Country
Belgium
City
Sarajevo
Country
Bosnia and Herzegovina
City
Tuzla
Country
Bosnia and Herzegovina
City
Belo Horizonte
State/Province
MG
Country
Brazil
City
Curitiba
State/Province
PR
Country
Brazil
City
Passo Fundo
State/Province
RS
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
City
Porto Alegre
State/Province
RS
Country
Brazil
City
Campinas
State/Province
SP
Country
Brazil
City
Santo Andre
State/Province
SP
Country
Brazil
City
Santos
State/Province
SP
Country
Brazil
City
Sao Paulo
State/Province
SP
Country
Brazil
City
Plovdiv
Country
Bulgaria
Facility Name
DDPPDI - Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Fifth MHAT-Sofia, AD
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT - Tokuda Hospital Sofia, AD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Military Medical Academy - MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
Country
Bulgaria
Facility Name
MHAT - Tokuda Hospital Sofia, AD
City
Stara Zagora
Country
Bulgaria
Facility Name
MHAT 'Dr. St. Cherkezov', AD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Chicoutimi
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
Facility Name
Hospital Clinico Regional Dr. Guillermo Grant Benavente
City
Concepcion
Country
Chile
Facility Name
Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio
City
Santiago
ZIP/Postal Code
56 2 5681332
Country
Chile
City
Santiago
Country
Chile
City
Temuco
Country
Chile
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Hradec Kralove
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Tabor
Country
Czech Republic
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Berlin
Country
Germany
City
Erlangen
Country
Germany
City
Goettingen
Country
Germany
City
Koeln
Country
Germany
City
Mainz
Country
Germany
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Debrecen
Country
Hungary
City
Fehergyarmat
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Principal SMO Dr. Bugyi Istvan Korhaz Szentes
City
Szentes
ZIP/Postal Code
6000
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
City
Secunderabad
State/Province
Andhra Pradesh
Country
India
City
Ahmedabad
State/Province
Gujarat
Country
India
City
Karamsad
State/Province
Gujarat
Country
India
City
Surat
State/Province
Gujarat
Country
India
City
Vadodara
State/Province
Gujarat
Country
India
City
Faridabad
State/Province
Haryana
Country
India
City
Srinagar
State/Province
Jammu & Kashmir
Country
India
City
Bangalore
State/Province
Karnataka
Country
India
City
Mangalore
State/Province
Karnataka
Country
India
City
Ernakulam
State/Province
Kerala
Country
India
City
Thrissur
State/Province
Kerala
Country
India
City
Trivandrum
State/Province
Kerala
Country
India
City
Cherthala
State/Province
Maharashtra
Country
India
City
Mumbai
State/Province
Maharashtra
Country
India
City
Nagpur
State/Province
Maharashtra
Country
India
City
Nashik
State/Province
Maharashtra
Country
India
City
Pune
State/Province
Maharashtra
Country
India
City
Mohali
State/Province
Punjab
Country
India
City
Bikaner
State/Province
Rajasthan
Country
India
Facility Name
Fortis Escort Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Apollo First Med Hospitals
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600010
Country
India
Facility Name
Life Line Multispecialty Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600096
Country
India
City
Chennai
State/Province
Tamil Nadu
Country
India
City
Coimbatore
State/Province
Tamil Nadu
Country
India
City
Lucknow
State/Province
Uttar Pradesh
Country
India
City
Kolkata
State/Province
West Bengal
Country
India
City
Delhi
Country
India
City
Afula
Country
Israel
City
Haifa
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Kfar Saba
Country
Israel
City
Ramat Gan
Country
Israel
City
Tel Aviv
Country
Israel
City
Liepaja
Country
Latvia
City
Rezekne
Country
Latvia
City
Valmiera
Country
Latvia
City
Ventspils
Country
Latvia
City
Beirut
Country
Lebanon
City
Arequipa
Country
Peru
City
Cuzco
Country
Peru
City
Lima
Country
Peru
City
Bydgoszcz
Country
Poland
City
Lancut
Country
Poland
City
Lodz
Country
Poland
City
Mielec
Country
Poland
City
Poznan
Country
Poland
City
Pulawy
Country
Poland
City
Engels
Country
Russian Federation
City
Niznhy Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Kragujevac
Country
Serbia
City
Nis
Country
Serbia
City
Novi Sad
Country
Serbia
City
Trnava
Country
Slovakia
City
Middelburg
State/Province
Mpumalanga
Country
South Africa
City
Bloemfontein
Country
South Africa
City
Dundee
Country
South Africa
City
Durban
Country
South Africa
City
Krugersdorp
Country
South Africa
City
Limpopo
Country
South Africa
City
Port Elizabeth
Country
South Africa
City
Pretoria
Country
South Africa
City
Somerset West
Country
South Africa
City
Worcester
Country
South Africa
City
Chernivci
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Poltava
Country
Ukraine
City
Sumy
Country
Ukraine
City
Vinnytsya
Country
Ukraine
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25115871
Citation
de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

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