Back to resultsA Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
Primary Purpose
Influenza
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
oseltamivir [Tamiflu]
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Secondary Outcome Measures
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436124
Brief Title
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment, no patients were enrolled
Study Start Date
January 2007 (Actual)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oseltamivir [Tamiflu]
Primary Outcome Measure Information:
Title
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Secondary Outcome Measure Information:
Title
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Genova
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
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