PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses
Intervention: Posaconazole oral suspension (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Schering-Plough
Summary
This phase II study will be conducted to:
1. 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
2. identify the dosing schedule that provides the most consistent therapeutic drug exposure
in this patient population.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 2000
Last updated: May 31, 2006
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