N/A
N=4,561
Influenza Resistance Information Study
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00884117 ↗Enrolled (actual)
4,561
Serious AEs
0.8%
Results posted
Jul 2016
Primary outcome: Primary: Number of Participants With Genotypic Resistance — 44; 1; 0; 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Oseltamivir (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Genotypic Resistance |
44; 1; 0; 2; 47; 0 | — |
| PRIMARY Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections |
NA; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir |
961; 12; 419; 323; 207 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir |
781; 10; 341; 258; 172 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir |
317; 4; 144; 110; 59 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir |
88; 44; 33; 11 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir |
1283; 583; 371; 329 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir |
1050; 453; 315; 282 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir |
628; 271; 181; 176 | — |
| SECONDARY Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir |
197; 73; 64; 60 | — |
| SECONDARY Time to Non-Detection of Viral RNA |
9.7; 8.2; 7.9 | <0.0001 sig |
| SECONDARY Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections |
9.5; 8.0; 8.0 | 0.015 sig |
| SECONDARY Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections |
9.9; 8.0; 8.0 | 0.0005 sig |
| SECONDARY Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections |
9.8; 10.0; 7.4 | 0.0002 sig |
| SECONDARY Viral Load Among Adults Treated With Oseltamivir |
5.8; 5.7; 5.8; 5.7; 5.9; 4.2 | — |
| SECONDARY Viral Load Among Children Treated With Oseltamivir |
5.8; 5.6; 5.7; 6.1; 4.5; 4.1 | — |
| SECONDARY Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses |
61.2; 55.9; 61.4 | 0.4464 |
| SECONDARY Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses |
15.3; 0; 15.8; 40.5; 10.2; 41.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load |
3.2; 96.8; 2.0; 98.0; 3.8; 96.2 | 0.2499 |
| SECONDARY Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir |
12.3; 11.4; 11.2; 13.2; 13.4; 3.7 | — |
| SECONDARY Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir |
12.4; 12.3; 11.9; 13.0; 3.3; 3.2 | — |
| SECONDARY Body Temperature Among Adults Treated With Oseltamivir |
38.0; 37.8; 37.8; 38.2; 38.0; 36.6 | — |
| SECONDARY Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir |
-1.4; -1.2; -1.7; -1.4 | — |
| SECONDARY Body Temperature Among Children Treated With Oseltamivir |
38.3; 38.3; 38.3; 38.2; 36.7; 36.6 | — |
| SECONDARY Change From Baseline in Body Temperature Among Children Treated With Oseltamivir |
-1.6; -1.6; -1.5; -1.6 | — |
Summary
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
Eligibility Criteria
Inclusion Criteria
- Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5)
- Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)
Exclusion Criteria
- Allergy to any potential influenza therapy
- Living in the same household or residential/care home as another study participant
Data sourced from ClinicalTrials.gov (NCT00884117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.