COMPARATIVE TRIAL OF MICAFUNGIN VERSUS FLUCONAZOLE FOR TREATING ESOPHAGEAL CANDIDIASIS.

Not Applicable

Completed

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

• Registration Number: PER-048-03
• Lead Sponsor: FUJISAWA HEALTH CARE INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07-23
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

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

Inclusion Criteria

1. The informed consent of the patient or his legally authorized representative must be obtained before entering the study.
2. Patients can be of both sexes.
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 prior to the administration of the first dose of the study medication. Histological / cytological confirmation should be obtained and by culture of brushing and esophageal biopsy, however the results may still be pending at the time of starting treatment with the study drug.
5. The patient should have sufficient venous access to allow administration.

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