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A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Comparator: Micafungin sodium
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.

Exclusion Criteria:

  • Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.
  • Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Caspofungin

    Micafungin

    Arm Description

    caspofungin acetate (MK0991)

    Micafungin sodium

    Outcomes

    Primary Outcome Measures

    Number of Participants With a Significant Drug-related Adverse Experience
    A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.

    Secondary Outcome Measures

    Number of Participants With a Specific Safety Finding
    A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.
    Number of Participants With Favorable Overall Response at the End of Study Therapy
    Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.

    Full Information

    First Posted
    July 16, 2008
    Last Updated
    February 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00717860
    Brief Title
    A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
    Official Title
    A Multicenter, Double-Blind, Comparative Study of MK0991 (Caspofungin) Versus Micafungin in Adult Japanese Patients With Deep-seated Candida or Aspergillus Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (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
    The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Caspofungin
    Arm Type
    Experimental
    Arm Description
    caspofungin acetate (MK0991)
    Arm Title
    Micafungin
    Arm Type
    Active Comparator
    Arm Description
    Micafungin sodium
    Intervention Type
    Drug
    Intervention Name(s)
    caspofungin acetate
    Intervention Description
    Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Micafungin sodium
    Intervention Description
    Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
    Primary Outcome Measure Information:
    Title
    Number of Participants With a Significant Drug-related Adverse Experience
    Description
    A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.
    Time Frame
    1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
    Secondary Outcome Measure Information:
    Title
    Number of Participants With a Specific Safety Finding
    Description
    A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.
    Time Frame
    1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
    Title
    Number of Participants With Favorable Overall Response at the End of Study Therapy
    Description
    Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.
    Time Frame
    1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp. Exclusion Criteria: Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp. Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23052987
    Citation
    Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y. A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis. Eur J Clin Microbiol Infect Dis. 2013 Mar;32(3):387-97. doi: 10.1007/s10096-012-1754-z. Epub 2012 Oct 3.
    Results Reference
    result

    Learn more about this trial

    A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)

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