None listed
Conditions
Interventions
Micafungin 150 mg will be administered for 14 days.
Group name:Fluconazole Type of group
200 mg intravenous fluconazole will be administered once a day for 14 days.
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Take blood sample for laboratory evaluations of hematology and serum chemistry. 2) Record deaths occurred within 2 weeks after the last day of the administration of the study drug. 3) Register antifungal therapy administered during the post-treatment period. 4) Evaluate and record the status of adverse events up to 72 hours after the last day of administration of the study drug. 5) Evaluate clinical signs and symptoms of candidiasis esophagitis and oropharyngeal candidiasis, if observed at baseline, using the graduation scales. 6) Perform an endoscopy of the esophagus IF the patient presents clinical symptoms of candidiasis esophagitis. Measure:Efficacy and safety of intravenous micafungin versus intravenous fluconazole in the treatment of patients with candidiasic esophagitis. Timepoints:2 weeks | — |
Countries
Brazil, Mexico, Peru, South Africa, United States
Outcome results
None listed