Clinical Trial: PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts
Brief Summary:
This phase II study will be conducted to:
- evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
- identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.
Detailed Summary:
This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.
The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: May 1, 2002
Date Started: January 2001
Date Completion:
Last Updated: December 30, 2015
Last Verified: December 2015
