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
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: oseltamivir [Tamiflu]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436124

Locations
Italy
Genova, Italy
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436124     History of Changes
Other Study ID Numbers: ML20910
Study First Received: February 15, 2007
Last Updated: December 18, 2007
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014