Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

Phase 3

Terminated

• Conditions: Invasive Fungal Infections
• Interventions: Drug: Placebo; Drug: Micafungin

• Registration Number: NCT00048750
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-11-06
• Study First Submitted QC: 2002-11-07
• Study First Posted: 2002-11-08
• Study Start: 2003-01
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Status Verified: 2008-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Micafungin	-

Primary Outcome Measures

Name	Time	Method
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study	Baseline through one week post-treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection	Baseline through one week post-treatment