A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Summary

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Timeline

Start

2008-02-04

Primary completion

2017-05-02

Completion

2017-05-02

Publications

• Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.

Drugs

Indications