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

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ClinicalTrials.gov Identifier: NCT00034671
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

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 Type : Interventional  (Clinical Trial)
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 : January 2001
Primary Completion Date : November 2001
Study Completion Date : March 2002

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U.S. FDA Resources





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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034671     History of Changes
Other Study ID Numbers: P01893
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis
Invasive Fungal Infections

Additional relevant MeSH terms:
Infection
Mycoses
Invasive Fungal Infections
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs