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

Condition(s) targeted: Fungal Infection

Intervention: caspofungin acetate (Drug); Comparator: Micafungin sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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

Official title: A Multicenter, Double-Blind, Comparative Study of MK0991 (Caspofungin) Versus Micafungin in Adult Japanese Patients With Deep-seated Candida or Aspergillus Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants With a Significant Drug-related Adverse Experience

Secondary outcome:

Number of Participants With a Specific Safety Finding

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: August 2008
Last updated: December 3, 2014