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Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

Primary Purpose

Aspergillosis, Candidiasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Children, 3 months through 17 years of age, with esophageal candidiasis or invasive candidiasis or children requiring salvage treatment of invasive aspergillosis.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)

    Secondary Outcome Measures

    The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
    The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type

    Full Information

    First Posted
    May 11, 2004
    Last Updated
    February 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00082524
    Brief Title
    Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
    Official Title
    A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (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 an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aspergillosis, Candidiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    caspofungin acetate
    Other Intervention Name(s)
    MK0991
    Intervention Description
    Duration of Treatment - 7-90 days
    Primary Outcome Measure Information:
    Title
    The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
    Secondary Outcome Measure Information:
    Title
    The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
    Title
    The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Children, 3 months through 17 years of age, with esophageal candidiasis or invasive candidiasis or children requiring salvage treatment of invasive aspergillosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19255017
    Citation
    Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. doi: 10.1542/peds.2008-1158.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSRSynopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

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