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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014