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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Fungal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Caspofungin

caspofungin acetate (MK0991)

Group Type EXPERIMENTAL

caspofungin acetate

Intervention Type DRUG

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.

Micafungin

Micafungin sodium

Group Type ACTIVE_COMPARATOR

Comparator: Micafungin sodium

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No