Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie micafungin's efficacy against invasive fungal infections in ICU patients?
How does micafungin compare to standard-of-care antifungals like fluconazole in prophylactic ICU trials?
Which biomarkers predict high-risk ICU patients for invasive fungal infections in NCT00048750?
What adverse events were observed in phase 3 micafungin trials for ICU prophylaxis and how were they managed?
Are there combination therapies involving micafungin and other echinocandins for invasive fungal infections in critical care?