None listed
Conditions
Interventions
Glass vials covered with light-protective film containing 50 mg of lyophilized micafungin (FK463) and 200 mg of lactose will be administered. Glass bottles containing 200 mg of fluconazole in 100 niL of 0.9% Sodium Chloride (concentration of 2 mg / mL).
Group name:Fluconazol Type of group
Glass bottles containing 200 mg of fluconazole in 100 mL of 0.9% Sodium Chloride (concentration of 2 mg / mL).
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
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
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:The primary evaluation point is the comparative incidence of success at the end of therapy. A two-tailed 95% confidence interval will be constructed for the difference in the success rates of micafungin and fluconazole (micafungin minus fluconazole). If the lower limit of the confidence interval is greater than 0.10, micafungin will be considered not inferior to fluconazole. If the lower limit of the confidence interval exceeds 0, micafungin will be considered superior to fluconazole. Measure:Efficacy and safety of intravenous micafungin versus intravenous fluconazole in the treatment of patients with candidiasic esophagitis. Timepoints:week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Not contemptible Measure:Not contemptible Timepoints:Not contemptible | — |
Countries
Brazil, Peru, South Africa
Outcome results
None listed