Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

Criteria

Inclusion Criteria:

• Proven or probable invasive fungal infections according to EORTC/MSG criteria.

• IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.

• Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria:

• History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.

• Concurrent progressive neurological disease (except if due to invasive fungal infection)

• Use of medications that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine.

• Females pregnant or nursing.