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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mycoses

Keywords

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Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis Invasive Fungal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Posaconazole oral suspension

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Countries

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Germany United States

References

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Ullmann AJ, Cornely OA, Burchardt A, Hachem R, Kontoyiannis DP, Topelt K, Courtney R, Wexler D, Krishna G, Martinho M, Corcoran G, Raad I. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob Agents Chemother. 2006 Feb;50(2):658-66. doi: 10.1128/AAC.50.2.658-666.2006.

Reference Type RESULT

PMID: 16436724 (View on PubMed)

Other Identifiers

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P01893

Identifier Type: -

Identifier Source: org_study_id