Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00034658

Collaborator

(none)

336

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:

A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Condition or Disease	Intervention/Treatment	Phase
Mycoses	Drug: Posaconazole	Phase 3

Detailed Description

The current clinical trial is designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections a)which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

336 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections

Study Start Date :

Dec 1, 1998

Actual Primary Completion Date :

Mar 1, 2002

Actual Study Completion Date :

Mar 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Proven or probable invasive fungal infections according to EORTC/MSG criteria.
IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.
Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria

Concurrent progressive neurological disease (except if due to invasive fungal infection)
Use of medications that are known to interact with azoles and that may lead to life-threatening side to effects.
Prior enrollment in this study.
Subjects with a life expectancy of less than 72 hours.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT00034658

Other Study ID Numbers:

P00041

First Posted:

May 2, 2002

Last Update Posted:

Mar 10, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Merck Sharp & Dohme LLC

Aspergillosis, Candidiasis, Cryptococcosis,

Additional relevant MeSH terms:

Mycoses

Invasive Fungal Infections

Posaconazole

Study Results

No Results Posted as of Mar 10, 2017