An Influenza Resistance Information Study (IRIS)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 15, 2009
Last updated: April 2, 2016
Last verified: April 2016

April 15, 2009
April 2, 2016
January 2009
November 2015   (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 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 ]
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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).
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Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
Patients presenting with clinical signs and symptoms of influenza during the local influenza season
Procedure: Virology testing
Virology testing (nasal/throat swabs) will be taken at baseline, and on days 3 and 6
Intervention: Procedure: Virology testing
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2015
November 2015   (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.
1 Year and older
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Hong Kong,   Netherlands,   Norway,   Poland
NV20237, 2008-006149-24
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2016

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