An Influenza Resistance Information Study (IRIS)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00884117
First received: April 15, 2009
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Procedure: Virology testing |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Natural prevalence and/or emergence of resistance to antivirals among influenza virus isolates [ Time Frame: Baseline, and days 3 and 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Genotypic and phenotypic characteristics of circulating viral strains [ Time Frame: Baseline, and days 3 and 6 ] [ Designated as safety issue: No ]
- Signs and symptoms of patients infected with different subtypes of seasonal influenza [ Time Frame: Baseline, and days 3 and 6 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Days 3 and 6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Virology testing
Virology testing (nasal/throat swabs) will be taken at baseline, and on days 3 and 6
|
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884117
Contacts
| Contact: Please reference Study ID Number: NV20237 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60655 | |
| Australia | |
| Recruiting | |
| Westmead, Australia, 2145 | |
| France | |
| Recruiting | |
| Bron, France, 69677 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 14052 | |
| Hong Kong | |
| Recruiting | |
| Shatin, Hong Kong | |
| Netherlands | |
| Active, not recruiting | |
| Rotterdam, Netherlands, 3000 CA | |
| Norway | |
| Completed | |
| Sandnes, Norway, 4313 | |
| Poland | |
| Recruiting | |
| Krakow, Poland, 31-159 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00884117 History of Changes |
| Other Study ID Numbers: | NV20237, 2008-006149-24 |
| Study First Received: | April 15, 2009 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France:Agence française de sécurité sanitaire des produits de santé |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013