Trial · NCT01314911
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
NCT01314911, Not applicable, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2019-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults. Trials, record NCT01314911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01314911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
- NCT number
- NCT01314911
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 716 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Influenza, Human
- Interventions
- Oseltamivir, Placebo
- First posted
- 2011-03-15
- Last updated
- 2019-02-05
- Results first posted
- 2019-02-05
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | At Day 3 | 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 | Number of Participants by Virus Detection Status--Team Collected Samples | At Day 0, 3 and 7 | 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 |
| Secondary | qPCR Viral Shedding -- Team Collected Samples | At Day 0, 3 and 7 | 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.) |
| Secondary | Number Of Participants Shedding Virus -- Team Collected Samples | At day 3 and 7. | 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). |
| Secondary | Time to Alleviation of Influenza Clinical Symptoms | From treatment initiation to Day 28 | 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. |
| Secondary | Time to Absence of Fever | From treatment initiation to Day 28 | 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. |
| Secondary | Time to Resolution of All Symptoms AND Fever | From treatment initiation to Day 28 | 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. |
| Secondary | Time to Feeling as Good as Before the Onset of the Influenza Illness | From treatment initiation to Day 28 | 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. |
| Secondary | Time to Return to Pre-influenza Function | From treatment initiation to Day 28 | 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. |
| Secondary | Time to Return of Physical Function to Pre-illness Level | From treatment initiation to Day 28 | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | At Day 3 | The population analyzed was restricted to the 455 participants who had a confirmed positive test (from team collected sample) for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC004. 6 participants (3 in each arm) had missing endpoint samples so were excluded from the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Virus Detection Status--Team Collected Samples | At Day 0, 3 and 7 | The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed(from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | qPCR Viral Shedding -- Team Collected Samples | At Day 0, 3 and 7 | The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing. | log10 copies/mL | MEDIAN |
| SECONDARY | Number Of Participants Shedding Virus -- Team Collected Samples | At day 3 and 7. | The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Alleviation of Influenza Clinical Symptoms | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
| SECONDARY | Time to Absence of Fever | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
| SECONDARY | Time to Resolution of All Symptoms AND Fever | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
| SECONDARY | Time to Feeling as Good as Before the Onset of the Influenza Illness | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
| SECONDARY | Time to Return to Pre-influenza Function | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
| SECONDARY | Time to Return of Physical Function to Pre-illness Level | From treatment initiation to Day 28 | The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. | days | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | Oseltamivir | 99 | Participants | ||
| Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | Placebo | 131 | Participants | ||
| Number of Participants by Virus Detection Status--Team Collected Samples | Oseltamivir | Day 0 / >= LLOQ | 237 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Placebo | Day 0 / >= LLOQ | 245 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Oseltamivir | Day 0 / >= LOD, < LLOQ | 6 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Placebo | Day 0 / >= LOD, < LLOQ | 5 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Oseltamivir | Day 0 / < LOD | 3 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Placebo | Day 0 / < LOD | 5 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Oseltamivir | Day 0 / Missing | 0 | Participants | |
| Number of Participants by Virus Detection Status--Team Collected Samples | Placebo | Day 0 / Missing | 0 | Participants |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oseltamivir | 278 | |
| Overall Study | STARTED | Placebo | 280 | |
| Overall Study | COMPLETED | Oseltamivir | 273 | |
| Overall Study | COMPLETED | Placebo | 274 | |
| Overall Study | NOT COMPLETED | Oseltamivir | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Oseltamivir | 65 | 277 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 61 | 279 | |
| other | Diarrhoea | Gastrointestinal disorders | Oseltamivir | 41 | 277 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 47 | 279 | |
| other | Vomiting | Gastrointestinal disorders | Oseltamivir | 35 | 277 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 36 | 279 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Oseltamivir | 28 | 277 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 32 | 279 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Oseltamivir | 24 | 277 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 25 | 279 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oseltamivir | 0 | 277 |
| Total, all-cause mortality | Placebo | 0 | 279 |
| Total, other adverse events | Oseltamivir | 134 | 277 |
| Total, other adverse events | Placebo | 153 | 279 |
| Total, serious adverse events | Oseltamivir | 5 | 277 |
| Total, serious adverse events | Placebo | 2 | 279 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oseltamivir vs Placebo: 28-day Mortality | Trial comparisons |
| Oseltamivir vs Placebo: Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples | Trial comparisons |
| Oseltamivir vs Placebo: Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | Trial comparisons |
| Oseltamivir vs Placebo: deaths from any cause | Trial comparisons |
| Oseltamivir vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01314911
GET https://conductscience.org/api/trials/v1/NCT01314911/results?page=2