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

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00436124
First received: February 15, 2007
Last updated: December 18, 2007
Last verified: December 2007

February 15, 2007
December 18, 2007
Not Provided
Not Provided
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Same as current
Complete list of historical versions of study NCT00436124 on ClinicalTrials.gov Archive Site
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
Same as current
Not Provided
Not Provided
 
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza
Drug: oseltamivir [Tamiflu]
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
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Not Provided

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00436124
ML20910
Not Provided
Not Provided
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP