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)

This study has been completed.

First Received: May 1, 2002 Last Updated: May 31, 2006 History of Changes

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00034671

Purpose

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	Intervention	Phase
Mycoses	Drug: Posaconazole oral suspension	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Posaconazole

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	100
Study Start Date:	October 2000

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

Ages Eligible for Study:	13 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	P01893
Study First Received:	May 1, 2002
Last Updated:	May 31, 2006
ClinicalTrials.gov Identifier:	NCT00034671 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis
Invasive Fungal Infections

Study placed in the following topic categories:

Anti-Bacterial Agents
Mycoses
Candidiasis
Antifungal Agents

Mucormycosis
Aspergillosis
Posaconazole
Cryptococcosis

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Mycoses
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses

Antifungal Agents
Antibiotics, Antifungal
Posaconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009