Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
- Registration Number
- NCT00666185
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 523
Inclusion Criteria
- Diagnosis of esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test in females of childbearing potential
Exclusion Criteria
- Pregnant or nursing
- Evidence of liver disease
- Presence of 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
- Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
- Non-responsive to therapy in any prior systemic antifungal clinical trail
- History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
- History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Fluconazole - 1 Micafungin -
- Primary Outcome Measures
Name Time Method Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy End of Therapy
- Secondary Outcome Measures
Name Time Method Clinical response at end of therapy of cleared or improved End of Therapy Mucosal response at end of therapy of cleared or improved End of Therapy
Trial Locations
- Locations (5)
2 Sites
🇿🇦Port Elizabeth, South Africa
4 Sites
🇵🇪Lima, Peru
8 Sites
🇧🇷Sao Paulo, Brazil
3 Sites
🇿🇦Pretoria, South Africa
5 Sites
🇧🇷Belo Horizonte, Brazil