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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oseltamivir [Tamiflu]

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No