PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00034671

Collaborator

(none)

Enrollment

13.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses	Drug: Posaconazole oral suspension	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Nov 1, 2001

Actual Study Completion Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.