Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)
Primary Purpose
Mycoses
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
About this trial
This is an interventional treatment trial for Mycoses focused on measuring Aspergillosis, Candidiasis, Cryptococcosis,
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034658
Brief Title
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)
Official Title
Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses
Keywords
Aspergillosis, Candidiasis, Cryptococcosis,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Posaconazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18813103
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)
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