Clinical Trial Protocol Registry
An Influenza Resistance Information Study (IRIS)
- Active, not recruiting
- Protocol number:
- Hoffmann-La Roche
- Company division:
- Official Scientific Title:
- An open label study to examine natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates, and of the clinical outcome of patients with influenza: Influenza Resistance Information Study (IRIS)
- Brief summary:
- This study will assist in the early detection of influenza resistant to antivirals, and will monitor the clinical outcome of patients infected with influenza according to subtype and susceptibility. Patients clinically diagnosed with influenza will undergo a rapid diagnostic test, and viral sampling at baseline and on days 3 and 6. Patients will be clinically managed according to local guidelines (no treatment, or treatment with neuraminidase inhibitors or other appropriate therapies). Target sample size is 4184.
- Study phase:
- Study type:
- Interventional; Diagnostic; Non-randomized; Open label; Uncontrolled; Single group; Efficacy study
- Primary outcome:
- Natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates Time frame: Baseline, and days 3 and 6
- Key secondary outcomes:
- Genotypic and phenotypic characteristics of circulating viral strains Time frame: Baseline, and days 3 and 6
- Signs and symptoms of patients infected with different subtypes of seasonal influenza Time frame: Baseline, and days 3 and 6
- Adverse events Time frame: Days 3 and 6
- Inclusion criteria:
- patients>=1 year of age;
- symptoms suggestive of influenza-like illness including, but not limited to, fever, cough or coryza.
- Exclusion criteria:
- allergy to any potential influenza therapy;
- more than one patient from same household or residential/care home.
- Males or Females
- Age limits:
- Min: 1 year Max: N/A N/A
- Accepts healthy volunteers:
- Anticipated start date:
- January, 2009
- Trial registration date:
- Date last updated:
- Westmead, New S
- Chicago, IL
For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.
- Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.
Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.
For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)
- 1-888-662-6728 Monday to Friday (6am to 3pm PST)