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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir [Tamiflu] (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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 and Contacts

Genova, Italy
Additional Information


Last updated: December 18, 2007

Page last updated: August 23, 2015

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