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

Phase 3

Completed

• Conditions: Fungal Infection
• Interventions: Drug: caspofungin acetate

• Registration Number: NCT00717860
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Study Start: 2008-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-28
• Results First Submitted QC: 2011-07-28
• Results First Posted: 2011-08-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caspofungin	caspofungin acetate	caspofungin acetate (MK0991)

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Significant Drug-related Adverse Experience	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	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

Name	Time	Method
Number of Participants With a Specific Safety Finding	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	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	1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis	Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.