Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Astellas

Status and phase: Completed; Phase 3

Conditions: Candidiasis, Oral

Treatments: Drug: Fluconazole; Drug: Micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666185

03-7-005

Details and patient eligibility

About

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Enrollment: 523 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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523 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Micafungin

2

Active Comparator group

Treatment:

Drug: Fluconazole