Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Astellas

Status and phase: Completed; Phase 3

Conditions: Candidiasis, Oral

Treatments: Drug: caspofungin; Drug: micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665639

03-7-008

Details and patient eligibility

About

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Enrollment: 454 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Esophageal candidiasis confirmed by endoscopy
• Negative pregnancy test for female patients of childbearing potential

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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454 participants in 3 patient groups

1

Experimental group

Description:

Daily dose

Treatment:

Drug: micafungin

2

Active Comparator group

Treatment:

Drug: caspofungin

3

Experimental group

Description:

Every other day dose, alternating with placebo

Treatment:

Drug: micafungin