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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00717860
First received: July 16, 2008
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.


Condition Intervention Phase
Fungal Infection
Drug: caspofungin acetate
Drug: Comparator: Micafungin sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Comparative Study of MK0991 (Caspofungin) Versus Micafungin in Adult Japanese Patients With Deep-seated Candida or Aspergillus Infections

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With a Significant Drug-related Adverse Experience [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ] [ Designated as safety issue: No ]
    Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.


Enrollment: 121
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofungin
caspofungin acetate (MK0991)
Drug: caspofungin acetate
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.
Active Comparator: Micafungin
Micafungin sodium
Drug: Comparator: Micafungin sodium
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717860

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00717860     History of Changes
Other Study ID Numbers: 0991-062, 2008_013
Study First Received: July 16, 2008
Results First Received: July 28, 2011
Last Updated: November 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Communicable Diseases
Infection
Mycoses
Caspofungin
Echinocandins
Micafungin
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014