Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Astellas Pharma Inc523 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

523

Conditions

Candidiasis, Oral

Interventions

MicafunginDRUG

FluconazoleDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (37)

Unnamed facility

Abadia Uberaba, Brazil

Outcomes

Primary Outcomes

Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy

Time frame: End of Therapy

Secondary Outcomes

Clinical response at end of therapy of cleared or improved

Time frame: End of Therapy

Mucosal response at end of therapy of cleared or improved

Time frame: End of Therapy

Data from ClinicalTrials.gov

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