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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
ClinicalTrials.gov Identifier:
NCT00717860
First received: July 16, 2008
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00717860     History of Changes
Other Study ID Numbers: MK-0991-062, 2008_013
Study First Received: July 16, 2008
Results First Received: July 28, 2011
Last Updated: September 6, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 19, 2013