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

Phase 4

Terminated

• Conditions: Influenza

• Registration Number: NCT00436124
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).

Secondary Outcome Measures

Name	Time	Method
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.