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

NCT ID: NCT00034658

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2002-03-31

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.

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.

Conditions

Mycoses

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Posaconazole

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Alexander BD, Perfect JR, Daly JS, Restrepo A, Tobon AM, Patino H, Hardalo CJ, Graybill JR. Posaconazole as salvage therapy in patients with invasive fungal infections after solid organ transplant. Transplantation. 2008 Sep 27;86(6):791-6. doi: 10.1097/TP.0b013e3181837585.

Reference Type: RESULT

PMID: 18813103 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

P00041

Identifier Type: -

Identifier Source: org_study_id