Trial information
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
Status: Terminated
Protocol number: ML20910
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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. Target sample size is 46.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Influenza
Intervention type: Drug
Intervention name: oseltamivir [Tamiflu]
Primary outcome: 1. Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Key secondary outcomes: 1. Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 64 Years
Accepts healthy volunteers: No
Trial registration date: 02/16/2007
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
