Trial · NCT00884117
Influenza Resistance Information Study
NCT00884117, Completed, Hoffmann-La Roche; results first posted 2016-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Influenza Resistance Information Study. Trials, record NCT00884117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884117
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Influenza Resistance Information Study
- NCT number
- NCT00884117
- Status
- Completed
- Enrollment
- 4,561 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Influenza
- Interventions
- Oseltamivir
- First posted
- 2009-04-20
- Last updated
- 2016-10-19
- Other registries' IDs
- eudract:2008-006149-24
- Results first posted
- 2016-07-19
- Limitations and caveats
This was a non-randomized, observational study and many comparisons were not powered to detect a true statistically significant difference between groups. Inferential analyses should be interpreted with caution.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Genotypic Resistance | Baseline (Day 1) and post-Baseline (Days 3, 6, 10) | Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, "H" stands for hemagglutinin and "N" stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.) |
| Primary | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7 | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported. |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Baseline (Day 1) | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Day 3 | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Day 6 | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Day 10 | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Baseline (Day 1) | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Day 3 | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Day 6 | |
| Secondary | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Day 10 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Genotypic Resistance | Baseline (Day 1) and post-Baseline (Days 3, 6, 10) | All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The Number of Participants Analyzed reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown. | participants | NUMBER |
| PRIMARY | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7 | ALCIP Population. The Number of Participants Analyzed reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Baseline (Day 1) | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Day 3 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Day 6 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Day 10 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Baseline (Day 1) | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Day 3 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Day 6 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table. | participants | NUMBER |
| SECONDARY | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Day 10 | ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table. | participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group243
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Baseline, H1N1 Seasonal (n=47) | 44 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Baseline, H1N1pdm09 (n=1240) | 1 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Baseline, H3N2 (n=1432) | 0 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Baseline, Influenza B (n=1006) | 2 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Baseline, All Types/Subtypes (n=3725) | 47 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Post-Baseline, H1N1 Seasonal (n=47) | 0 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Post-Baseline, H1N1pdm09 (n=1240) | 39 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Post-Baseline, H3N2 (n=1432) | 18 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Post-Baseline, Influenza B (n=1006) | 0 | participants | |
| Number of Participants With Genotypic Resistance | Otherwise Healthy Participants Infected With Influenza | Post-Baseline, All Types/Subtypes (n=3725) | 57 | participants |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants Infected With Influenza | 4,561 | |
| Overall Study | COMPLETED | All Participants Infected With Influenza | 4,312 | |
| Overall Study | NOT COMPLETED | All Participants Infected With Influenza | 249 |
Source ClinicalTrials.gov
Adverse events56
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 |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Participants Treated With Oseltamivir | 5 | 2,578 | |
| serious | Pneumonia | Infections and infestations | Participants Not Treated With Oseltamivir | 1 | 1,975 | |
| serious | Bronchitis | Infections and infestations | Participants Treated With Oseltamivir | 0 | 2,578 | |
| serious | Bronchitis | Infections and infestations | Participants Not Treated With Oseltamivir | 2 | 1,975 | |
| serious | Bronchiolitis | Infections and infestations | Participants Treated With Oseltamivir | 1 | 2,578 | |
| serious | Bronchiolitis | Infections and infestations | Participants Not Treated With Oseltamivir | 0 | 1,975 | |
| serious | Bronchopneumonia | Infections and infestations | Participants Treated With Oseltamivir | 1 | 2,578 | |
| serious | Bronchopneumonia | Infections and infestations | Participants Not Treated With Oseltamivir | 0 | 1,975 | |
| serious | Cellulitis | Infections and infestations | Participants Treated With Oseltamivir | 1 | 2,578 | |
| serious | Cellulitis | Infections and infestations | Participants Not Treated With Oseltamivir | 0 | 1,975 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Treated With Oseltamivir | ||
| Total, all-cause mortality | Participants Not Treated With Oseltamivir | ||
| Total, other adverse events | Participants Treated With Oseltamivir | 0 | 2,578 |
| Total, other adverse events | Participants Not Treated With Oseltamivir | 0 | 1,975 |
| Total, serious adverse events | Participants Treated With Oseltamivir | 24 | 2,578 |
| Total, serious adverse events | Participants Not Treated With Oseltamivir | 11 | 1,975 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Participants Treated With Oseltamivir vs Participants Not Treated With Oseltamivir: serious adverse events |
Source 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/NCT00884117
GET https://conductscience.org/api/trials/v1/NCT00884117/registered?page=2