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

Not Applicable

• Conditions: Candidiasis, unspecified; B379; -B379 Candidiasis, unspecified

• Registration Number: PER-046-04
• Lead Sponsor: FUJISAWA HEALTH CARE INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Comparative incidence of success, defined as the complete elimination of esophageal lesions<br>Measure:Comparative incidence of success, defined as the complete elimination of esophageal lesions<br>Timepoints:day 14<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:General therapeutic response<br>Measure:General therapeutic response<br>Timepoints:day 14<br>