Influenza Resistance Information Study (IRIS)

Roche

Status: Completed

Conditions: Influenza

Treatments: Drug: Oseltamivir

Study type: Observational

Funder types: Industry

Identifiers

NCT00884117

2008-006149-24 (EudraCT Number)

NV20237

Details and patient eligibility

About

This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.

Enrollment: 4,561 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5)
• Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)

Exclusion criteria

• Allergy to any potential influenza therapy
• Living in the same household or residential/care home as another study participant

Trial design

4,561 participants in 1 patient group

Participants Infected with Influenza

Description:

Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled and followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. Participants may receive treatment including oseltamivir, other treatment/medication, or no treatment.

Treatment:

Drug: Oseltamivir