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

Roche

Status and phase

Terminated

Phase 4

Conditions

Influenza

Treatments

Drug: oseltamivir [Tamiflu]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00436124

ML20910

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.