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

Mycoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034658
• Other study ID #: P00041
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2002
• Last updated: March 7, 2017
• Start date: December 1998
• Est. completion date: March 2002

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mycoses

Intervention

Drug:
• Posaconazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Alexander BD, Perfect JR, Daly JS, Restrepo A, Tobón 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 — View Citation