Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)

Summary

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Timeline

Start

1998-12

Primary completion

2002-03

Completion

2002-03

Publications

• Results Alexander BD, Perfect JR, Daly JS, Restrepo A, Tobon AM, Patino H, Hardalo CJ, Graybill JR. Posaconazole as salvage therapy in patients with invasive fungal infections after solid organ transplant. Transplantation. 2008 Sep 27;86(6):791-6. doi: 10.1097/TP.0b013e3181837585.

Drugs

Indications