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Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Oseltamivir
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human focused on measuring H1N1, Complications, PCR, Seasonal Influenza, Viral Shedding

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent prior to initiation of any study procedures

  • History of an influenza-like illness defined as:

    1) One or more respiratory symptom (cough, sore throat, or nasal symptoms)

  • Onset of illness no more than 48 hours before screening, defined as when the participant experienced at least one respiratory symptom
  • Willing to have samples stored
  • Positive test for influenza (either rapid antigen or polymerase chain reaction [PCR]); randomization could proceed in cases of discrepant results (one positive and one negative)

Exclusion Criteria:

  • Hospitalization at the time of screening

  • Presence of a medical condition(s) that had been associated with increased risk of complications from influenza

    1. Aged 65 years of age or older
    2. Asthma
    3. Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle, such as cerebral palsy, epilepsy [seizure disorders], stroke, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
    4. Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis)
    5. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
    6. Blood disorders
    7. Endocrine disorders (such as diabetes mellitus)
    8. Kidney disorders
    9. Liver disorders
    10. Metabolic disorders (such as inherited metabolic disorders or mitochondrial disorders)
    11. Weakened immune system due to disease or medication (such as people with HIV/AIDS or cancer, or use of chronic steroids or other medications causing immune suppression)
    12. Pregnant or 4 weeks postpartum
    13. Body mass index (BMI) greater than or equal to 40
  • Breastfeeding
  • Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication
  • Received more than one dose of any antiviral influenza medication since onset of influenza symptoms
  • Known end stage kidney dysfunction (e.g., creatinine clearance less than 30 mL/min)
  • Known hypersensitivity to oseltamivir, peramivir, or zanamivir
  • Received live attenuated influenza virus vaccine within 3 weeks prior to study entry
  • Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry
  • Participated in other research protocols that required more than 100mL of blood to be drawn in a 4-week period that overlapped with this study.

Sites / Locations

  • East Valley Family Physicians
  • WCCT Global, LLC
  • Paragon Rx Clinical
  • University of Southern California
  • University of California, San Diego
  • Westlake Medical Research
  • Advanced Rx Clinical Research Group
  • University of Colorado
  • University of Florida
  • Best Quality Research, Inc.
  • Medical Consulting Center
  • Suncoast Research Group, LLC
  • DMI Research, Inc.
  • Columbus Regional Research Institute
  • University of Iowa
  • Research Integrity, LLC
  • Horizon Research Group of Opelousas, LLC
  • Michael Seep, MD; Centex Studies
  • National Institutes of Health, Laboratory of Immunoregulation
  • Brigham and Women's Hospital
  • Skyline Medical Center
  • Prairie Fields Family Medicine
  • Southwest Family Physicians
  • Clinical Research Advantage, Inc.
  • New Jersey Medical School
  • NYU School of Medicine
  • Mount Sinai Medical Center
  • University of Rochester Medical Center
  • Great Lakes Medical Research
  • Clinical Research Solutions
  • University of Pennsylvania, Division of Infectious Disease
  • Frontier Clinical Research, LLC
  • Health Concepts
  • Clinical Research Solutions
  • Clinical Research Solutions
  • Clinical Research Solutions
  • Clinical Research Solutions
  • University of Texas Tech Amarillo
  • University of Texas Health Science Center at Houston
  • Centex Studies
  • Texas Tech University Health Sciences Center
  • Village Health Partners
  • Bandera Family Health Care
  • Virginia Commonwealth University Medical Center
  • Hospital General de Agudos J. M. Ramos Mejía
  • Hospital Municipal "Prof. Dr. Bernardo A. Houssay"
  • Hospital Público Descentralizado Dr. Guillermo Rawson
  • The Bamrasnaradura Infectious Diseases Institute
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
  • Siriraj Hospital
  • Khon Kaen University (Department of Medicine)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oseltamivir

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.

Secondary Outcome Measures

Number of Participants by Virus Detection Status--Team Collected Samples
Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ
qPCR Viral Shedding -- Team Collected Samples
Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)
Number Of Participants Shedding Virus -- Team Collected Samples
Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).
Time to Alleviation of Influenza Clinical Symptoms
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.
Time to Absence of Fever
Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.
Time to Resolution of All Symptoms AND Fever
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.
Time to Feeling as Good as Before the Onset of the Influenza Illness
Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Time to Return to Pre-influenza Function
Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Time to Return of Physical Function to Pre-illness Level
Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment). For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.
Number of Participants With Treatment Compliance Status
For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.
Percentage of Participants Who Required Hospitalization.
The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.
28-day Mortality
Number of deaths
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples
For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.
Number of Participants by Virus Detection Status --Self Collected Samples
Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
qPCR Viral Shedding -- Self Collected Samples
Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples
This AUC was calculated using the trapezoidal rule and the units of measurement are (days*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.

Full Information

First Posted
March 3, 2011
Last Updated
January 11, 2019
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01314911
Brief Title
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
Official Title
A Randomized Double-Blind Study Comparing Oseltamivir Versus Placebo for the Treatment of Influenza in Low Risk Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 18, 2017 (Actual)
Study Completion Date
November 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
People who are infected with the influenza virus may develop respiratory illnesses, such as pneumonia, or other life-threatening complications. Currently, there are four antiviral medications that are used to treat influenza. This study will examine one of these medications, oseltamivir, to examine how it affects the shedding of influenza virus in infected people.
Detailed Description
Seasonal influenza is responsible for excess hospitalizations and, despite effective antivirals, causes significant morbidity and mortality (about 24,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S.) but in contrast to seasonal flu, nearly 90% of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. Although there are four currently licensed anti-influenza medications (amantadine and rimantadine, oseltamivir, and zanamivir), previous studies have not demonstrated conclusively to what extent these medications affect influenza viral shedding. This study will evaluate whether oseltamivir modifies the viral shedding during the treatment of uncomplicated influenza in an adult population and also assess methods to detect viral replication in the upper respiratory tract. Subjects who presented with an influenza-like illness without any risk factors for severe disease were screened for the study. Those with a confirmatory test for influenza (rapid antigen or polymerase chain reaction [PCR]) were randomized in a 1:1 manner to receive a blinded study treatment consisting of either the oseltamivir or placebo for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, and 28 were used for both safety and efficacy analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
H1N1, Complications, PCR, Seasonal Influenza, Viral Shedding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
716 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oseltamivir
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
Primary Outcome Measure Information:
Title
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples
Description
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.
Time Frame
At Day 3
Secondary Outcome Measure Information:
Title
Number of Participants by Virus Detection Status--Team Collected Samples
Description
Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ
Time Frame
At Day 0, 3 and 7
Title
qPCR Viral Shedding -- Team Collected Samples
Description
Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)
Time Frame
At Day 0, 3 and 7
Title
Number Of Participants Shedding Virus -- Team Collected Samples
Description
Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).
Time Frame
At day 3 and 7.
Title
Time to Alleviation of Influenza Clinical Symptoms
Description
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.
Time Frame
From treatment initiation to Day 28
Title
Time to Absence of Fever
Description
Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.
Time Frame
From treatment initiation to Day 28
Title
Time to Resolution of All Symptoms AND Fever
Description
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.
Time Frame
From treatment initiation to Day 28
Title
Time to Feeling as Good as Before the Onset of the Influenza Illness
Description
Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Time Frame
From treatment initiation to Day 28
Title
Time to Return to Pre-influenza Function
Description
Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.
Time Frame
From treatment initiation to Day 28
Title
Time to Return of Physical Function to Pre-illness Level
Description
Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment). For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.
Time Frame
From treatment initiation to Day 28
Title
Number of Participants With Treatment Compliance Status
Description
For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.
Time Frame
From treatment initiation to Day 5
Title
Percentage of Participants Who Required Hospitalization.
Description
The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).
Time Frame
From treatment initiation to Day 28
Title
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.
Description
Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.
Time Frame
From treatment initiation to Day 28
Title
28-day Mortality
Description
Number of deaths
Time Frame
From treatment initiation to Day 28
Title
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples
Description
For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.
Time Frame
At Day 3
Title
Number of Participants by Virus Detection Status --Self Collected Samples
Description
Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Time Frame
At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3
Title
qPCR Viral Shedding -- Self Collected Samples
Description
Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Time Frame
At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3
Title
Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples
Description
This AUC was calculated using the trapezoidal rule and the units of measurement are (days*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.
Time Frame
From Day 0 to Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent prior to initiation of any study procedures History of an influenza-like illness defined as: 1) One or more respiratory symptom (cough, sore throat, or nasal symptoms) Onset of illness no more than 48 hours before screening, defined as when the participant experienced at least one respiratory symptom Willing to have samples stored Positive test for influenza (either rapid antigen or polymerase chain reaction [PCR]); randomization could proceed in cases of discrepant results (one positive and one negative) Exclusion Criteria: Hospitalization at the time of screening Presence of a medical condition(s) that had been associated with increased risk of complications from influenza Aged 65 years of age or older Asthma Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle, such as cerebral palsy, epilepsy [seizure disorders], stroke, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis) Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease) Blood disorders Endocrine disorders (such as diabetes mellitus) Kidney disorders Liver disorders Metabolic disorders (such as inherited metabolic disorders or mitochondrial disorders) Weakened immune system due to disease or medication (such as people with HIV/AIDS or cancer, or use of chronic steroids or other medications causing immune suppression) Pregnant or 4 weeks postpartum Body mass index (BMI) greater than or equal to 40 Breastfeeding Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication Received more than one dose of any antiviral influenza medication since onset of influenza symptoms Known end stage kidney dysfunction (e.g., creatinine clearance less than 30 mL/min) Known hypersensitivity to oseltamivir, peramivir, or zanamivir Received live attenuated influenza virus vaccine within 3 weeks prior to study entry Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry Participated in other research protocols that required more than 100mL of blood to be drawn in a 4-week period that overlapped with this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Beigel, MD
Organizational Affiliation
Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, National Institutes of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Ison, MD, MS
Organizational Affiliation
Division of Infectious Disease, Feinberg School of Medicine, Northwestern University
Official's Role
Study Chair
Facility Information:
Facility Name
East Valley Family Physicians
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
WCCT Global, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Paragon Rx Clinical
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Westlake Medical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Advanced Rx Clinical Research Group
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0186
Country
United States
Facility Name
Best Quality Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33106
Country
United States
Facility Name
Medical Consulting Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
DMI Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Horizon Research Group of Opelousas, LLC
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Michael Seep, MD; Centex Studies
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
National Institutes of Health, Laboratory of Immunoregulation
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Skyline Medical Center
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Prairie Fields Family Medicine
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Southwest Family Physicians
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Great Lakes Medical Research
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
University of Pennsylvania, Division of Infectious Disease
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Clinical Research Solutions
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Clinical Research Solutions
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Clinical Research Solutions
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
University of Texas Tech Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centex Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Bandera Family Health Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Hospital General de Agudos J. M. Ramos Mejía
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Municipal "Prof. Dr. Bernardo A. Houssay"
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Público Descentralizado Dr. Guillermo Rawson
City
Cordoba
ZIP/Postal Code
05000
Country
Argentina
Facility Name
The Bamrasnaradura Infectious Diseases Institute
City
Mueang Nonthaburi
State/Province
Nonthaburi
ZIP/Postal Code
1100
Country
Thailand
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Khon Kaen University (Department of Medicine)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
12517228
Citation
Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.
Results Reference
background
PubMed Identifier
16494718
Citation
Monto AS. Vaccines and antiviral drugs in pandemic preparedness. Emerg Infect Dis. 2006 Jan;12(1):55-60. doi: 10.3201/eid1201.051068.
Results Reference
background
PubMed Identifier
31541242
Citation
Beigel JH, Manosuthi W, Beeler J, Bao Y, Hoppers M, Ruxrungtham K, Beasley RL, Ison M, Avihingsanon A, Losso MH, Langlois N, Hoopes J, Lane HC, Holley HP, Myers CA, Hughes MD, Davey RT. Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial. Clin Infect Dis. 2020 May 23;70(11):2317-2324. doi: 10.1093/cid/ciz634.
Results Reference
derived
Links:
URL
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables
Description
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).

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Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

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