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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00884117




Registration number
NCT00884117
Ethics application status
Date submitted
15/04/2009
Date registered
20/04/2009
Date last updated
19/10/2016

Titles & IDs
Public title
Influenza Resistance Information Study
Scientific title
Influenza Resistance Information Study (IRIS)
Secondary ID [1] 0 0
2008-006149-24
Secondary ID [2] 0 0
NV20237
Universal Trial Number (UTN)
Trial acronym
IRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Oseltamivir

Participants Infected with Influenza - Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled and followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. Participants may receive treatment including oseltamivir, other treatment/medication, or no treatment.


Treatment: Drugs: Oseltamivir
Participants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Genotypic Resistance
Timepoint [1] 0 0
Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Primary outcome [2] 0 0
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Timepoint [2] 0 0
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 outcome [1] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Timepoint [1] 0 0
Baseline (Day 1)
Secondary outcome [2] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Timepoint [2] 0 0
Day 3
Secondary outcome [3] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Timepoint [3] 0 0
Day 6
Secondary outcome [4] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Timepoint [4] 0 0
Day 10
Secondary outcome [5] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Timepoint [5] 0 0
Baseline (Day 1)
Secondary outcome [6] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Timepoint [6] 0 0
Day 3
Secondary outcome [7] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Timepoint [7] 0 0
Day 6
Secondary outcome [8] 0 0
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Timepoint [8] 0 0
Day 10
Secondary outcome [9] 0 0
Time to Non-Detection of Viral RNA
Timepoint [9] 0 0
From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Secondary outcome [10] 0 0
Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
Timepoint [10] 0 0
From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Secondary outcome [11] 0 0
Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
Timepoint [11] 0 0
From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Secondary outcome [12] 0 0
Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
Timepoint [12] 0 0
From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Secondary outcome [13] 0 0
Viral Load Among Adults Treated With Oseltamivir
Timepoint [13] 0 0
Days 1, 3, 6, 10
Secondary outcome [14] 0 0
Viral Load Among Children Treated With Oseltamivir
Timepoint [14] 0 0
Days 1, 3, 6, 10
Secondary outcome [15] 0 0
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Timepoint [15] 0 0
Day 6
Secondary outcome [16] 0 0
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Timepoint [16] 0 0
Days 3, 6, 10
Secondary outcome [17] 0 0
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Timepoint [17] 0 0
Baseline (Day 1)
Secondary outcome [18] 0 0
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Timepoint [18] 0 0
Days 1, 6, 10
Secondary outcome [19] 0 0
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Timepoint [19] 0 0
Days 1, 6, 10
Secondary outcome [20] 0 0
Body Temperature Among Adults Treated With Oseltamivir
Timepoint [20] 0 0
Days 1, 10
Secondary outcome [21] 0 0
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Timepoint [21] 0 0
Baseline (Day 1) to Day 10
Secondary outcome [22] 0 0
Body Temperature Among Children Treated With Oseltamivir
Timepoint [22] 0 0
Days 1, 10
Secondary outcome [23] 0 0
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Timepoint [23] 0 0
Baseline (Day 1) to Day 10

Eligibility
Key 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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Allergy to any potential influenza therapy
* Living in the same household or residential/care home as another study participant

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
4561
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
France
State/province [2] 0 0
Bron
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Shatin
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam
Country [6] 0 0
Norway
State/province [6] 0 0
Sandnes
Country [7] 0 0
Poland
State/province [7] 0 0
Krakow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00884117
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00884117