- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436124
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
February 16, 2017 updated by: Hoffmann-La Roche
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
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 Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Genova, Italy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
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Secondary Outcome Measures
Outcome Measure |
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Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2007
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 15, 2007
First Posted (Estimate)
February 16, 2007
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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