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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Fungal Infection

Treatments: Drug: caspofungin acetate; Drug: Comparator: Micafungin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717860

2008_013

0991-062

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups

Caspofungin

Experimental group

Description:

caspofungin acetate (MK0991)

Treatment:

Drug: caspofungin acetate

Micafungin

Active Comparator group

Description:

Micafungin sodium

Treatment:

Drug: Comparator: Micafungin sodium