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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00436124
• Other study ID #: ML20910
• Status: Terminated
• Phase: Phase 4
• First received: February 15, 2007
• Last updated: February 16, 2017
• Start date: January 2007
• Est. completion date: April 2007

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• oseltamivir [Tamiflu]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Secondary	Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.