Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
- Registration Number
- NCT00105144
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.
- Detailed Description
The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
Inclusion Criteria
- Patients must have candidemia or invasive candidiasis.
Exclusion Criteria
- Patients who have received an echinocandin within one month prior to study entry.
- Patients who have received more than two days of prior systemic antifungal therapy for the current infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Micafungin lower dose 2 Micafungin higher dose 3 Caspofungin -
- Primary Outcome Measures
Name Time Method Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy End of therapy and 6 weeks post-treatment
- Secondary Outcome Measures
Name Time Method Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy End of therapy and 6 weeks post-treatment