Clinical trial NCT00884117: Influenza Resistance Information Study
Official title: Influenza Resistance Information Study (IRIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 4561
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled.

Brief 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

Primary outcomes:
measure: Number of Participants With Genotypic Resistance
timeFrame: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
measure: Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
timeFrame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
Secondary outcomes:
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
timeFrame: Baseline (Day 1)
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
timeFrame: Day 3
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
timeFrame: Day 6
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
timeFrame: Day 10
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
timeFrame: Baseline (Day 1)
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
timeFrame: Day 3
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
timeFrame: Day 6
measure: Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
timeFrame: Day 10
measure: Time to Non-Detection of Viral RNA
timeFrame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
measure: Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
timeFrame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
measure: Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
timeFrame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
measure: Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
timeFrame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
measure: Viral Load Among Adults Treated With Oseltamivir
timeFrame: Days 1, 3, 6, 10
measure: Viral Load Among Children Treated With Oseltamivir
timeFrame: Days 1, 3, 6, 10
measure: Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
timeFrame: Day 6
measure: Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
timeFrame: Days 3, 6, 10
measure: Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
timeFrame: Baseline (Day 1)
measure: Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
timeFrame: Days 1, 6, 10
measure: Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
timeFrame: Days 1, 6, 10
measure: Body Temperature Among Adults Treated With Oseltamivir
timeFrame: Days 1, 10
measure: Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
timeFrame: Baseline (Day 1) to Day 10
measure: Body Temperature Among Children Treated With Oseltamivir
timeFrame: Days 1, 10
measure: Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
timeFrame: Baseline (Day 1) to Day 10
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Westmead
country: Australia
state: New South Wales
city: Bron
country: France
city: Berlin
country: Germany
city: Shatin
country: Hong Kong
city: Rotterdam
country: Netherlands
city: Sandnes
country: Norway
city: Krakow
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939.
citation: Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7.