Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts

Merck Sharp & Dohme LLC0 sites98 target enrollmentJanuary 2001

ConditionsMycoses

DrugsPosaconazole oral suspension

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Mycoses
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 98
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 Description

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.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

March 2002

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies.
•Subjects who received \>72 hours of systemic empiric antibacterial therapy and are neutropenic (\<500 neutrophils per mm3 and, have had fever that has reached an oral temperature \>38c (or \>100.4f)twice in the last 48 hours, or
•have a recurrence of fever (oral temperature, \>38c or \>100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.
•Able to take oral medication or take medication via enteral feeding tube.