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An Influenza Resistance Information Study (IRIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Hoffmann-La Roche
Sponsor:
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

April 15, 2009
May 7, 2013
December 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00884117 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
An Influenza Resistance Information Study (IRIS)
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)

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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Influenza
Procedure: Virology testing
Virology testing (nasal/throat swabs) will be taken at baseline, and on days 3 and 6
Experimental: 1
Intervention: Procedure: Virology testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
1 Year and older
No
Contact: Please reference Study ID Number: NV20237 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Australia,   France,   Germany,   Hong Kong,   Netherlands,   Norway,   Poland
 
NCT00884117
NV20237, 2008-006149-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP