Status:

COMPLETED

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Influenza

Eligibility:

All Genders

1+ years

Phase:

PHASE4

Brief Summary

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant r...

Eligibility Criteria

Inclusion

  • Negative rapid diagnostic test for influenza at baseline;
  • Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion

  • Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
  • Influenza vaccination in 6 weeks prior to randomization;
  • Positive rapid diagnostic test for influenza;
  • Solid organ transplant within 6 months of randomization;
  • Antiviral treatment for influenza in 2 weeks prior to randomization.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

477 Patients enrolled

Trial Details

Trial ID

NCT00412737

Start Date

January 1 2007

End Date

May 1 2008

Last Update

June 10 2016

Active Locations (78)

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Page 1 of 20 (78 locations)

1

Birmingham, Alabama, United States, 35233

2

Little Rock, Arkansas, United States, 72202

3

Stanford, California, United States, 94305

4

Denver, Colorado, United States, 80262

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants | DecenTrialz