Influenza
Conditions
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.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs. | — |
Countries
Italy
Outcome results
None listed