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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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycoses focused on measuring Aspergillosis, Candidiasis, Cryptococcosis,

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 1, 2002
    Last Updated
    March 7, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    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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