Status:
COMPLETED
Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of 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 daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
Eligibility Criteria
Inclusion
- Esophageal candidiasis confirmed by endoscopy
- Negative pregnancy test for female patients of childbearing potential
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00665639
Start Date
June 1 2004
End Date
December 1 2004
Last Update
August 20 2014
Active Locations (31)
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1
5 Sites
Buenos Aires, Argentina
2
Córdoba, Argentina
3
Neuquén, Argentina
4
Santa Fe, Argentina