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

Roche

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Drug: Oseltamivir

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412737

NV20235

Details and patient eligibility

About

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 recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Enrollment

477 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.