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

Phase 4TerminatedNCT00436124

Hoffmann-La Roche

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Influenza

Interventions

oseltamivir [Tamiflu]DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Genova, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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