A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.

A Randomized, Open Label Study to Evaluate the Effect of Tamiflu on Viral Shedding and on Serum and Cytoplasmic Inflammatory Cytokine Concentrations in Patients With Laboratory-confirmed Influenza

This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 18-64 years of age;
• ambulatory;
• influenza-like illness;
• positive rapid assay for detection of influenza antigen.

Exclusion Criteria:

• presentation >36h after onset of symptoms;
• influenza-like symptoms outside an outbreak based on local surveillance activities;
• influenza vaccination between November 2006 and January 2007;
• receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.