Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis
- Registration Number
- NCT00665639
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 454
Inclusion Criteria
- Esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test for female patients of childbearing potential
Exclusion Criteria
- Pregnant or nursing female patient
- Evidence of liver disease
- Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
- Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
- Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
- Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
- Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
- History of anaphylaxis attributed to echinocandin class of antifungals
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 micafungin Every other day dose, alternating with placebo 1 micafungin Daily dose 2 caspofungin -
- Primary Outcome Measures
Name Time Method Comparative incidence of success, defined as complete clearing of esophageal lesions End of Therapy
- Secondary Outcome Measures
Name Time Method Clinical response End of Therapy Mycological response End of Therapy Overall therapeutic response End of Therapy
Trial Locations
- Locations (5)
7 Sites
🇧🇷Sao Paulo, Brazil
3 Sites
🇧🇷Belo Horizonte, Brazil
5 Sites
🇦🇷Buenos Aires, Argentina
2 Sites
🇿🇦Port Elizabeth, South Africa
4 Sites
🇵🇪Lima, Peru