Status:
COMPLETED
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Candidiasis, Oral
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
Eligibility Criteria
Inclusion
- Diagnosis of esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test in females of childbearing potential
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT00666185
Start Date
August 1 2003
End Date
February 1 2004
Last Update
September 18 2014
Active Locations (37)
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1
Abadia Uberaba, Brazil
2
Barretos, Brazil
3
5 Sites
Belo Horizonte, Brazil
4
Boqueirao - Santos, Brazil