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

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00717860

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:

MedlinePlus related topics: Fungal Infections

Drug Information available for: Caspofungin Caspofungin Acetate Micafungin sodium

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

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 23, 2012