Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis.

Not Applicable

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

• Registration Number: PER-055-03
• Lead Sponsor: FUJISAWA HEALTH CARE INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-09-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. The informed consent of the patient or his / her patient must be obtained legally authorized representative before entering the study.
2. Patients can be of both sexes. Women with the ability to get pregnant should have a negative pregnancy test.
3. Patients 16 years of age or older.
4. Patients should present candidiasic esophagitis confirmed by
endoscopy and documented by typical clinical symptoms within 5
days before the administration of the first dose of the medication of the study.
5. The patient should have enough venous accesses that allow
administer the study medication and monitor the variables of
security.

Exclusion Criteria

1. Pregnant or nursing patient. Women of childbearing age should avoid pregnancy while receiving the study drug.
2. Evidence of liver disease, defined either by:
a. Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase> 10 times the upper limit of the normal value (ULN).
b. Total bilirubin> 5 times ULN.
3. Patients with another active opportunistic fungal infection and / or receiving acute systemic therapy for an opportunistic fungal infection.
4. The patient with concomitant esophagitis caused by herpes simplex virus or cytomegalovirus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified