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

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 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.

Timeline

Start

2007-01

Primary completion

2008-05

Completion

2008-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Oseltamivir; p = 0.772; Relative Risk Reduction 0.283 (95% CI -2.3 to 4.1); Fisher Exact NCT00412737 ↗

paper In the intent-to-treat population, the frequency of laboratory-confirmed clinical influenza (culture positive and/or >4-fold increase in haemagglutinin antibody inhibition [primary end point]) was similar in the oseltamivir and placebo groups PMID 22728756 ↗

Publications

• Ison MG, Szakaly P, Shapira MY, Krivan G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oseltamivir	Small molecule	30 mg	Oral
Subject	Oseltamivir	Small molecule	75 mg	Oral

Indications