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

Phase 3CompletedNCT00717860

Merck Sharp & Dohme LLC121 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

Conditions

Fungal Infection

Interventions

caspofungin acetateDRUG

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.

Comparator: Micafungin sodiumDRUG

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

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With a Significant Drug-related Adverse Experience

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.

Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis

Secondary Outcomes

Number of Participants With a Specific Safety Finding

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.

Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis

Number of Participants With Favorable Overall Response at the End of Study Therapy

Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.

Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis

Data from ClinicalTrials.gov

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