None listed
Conditions
Interventions
Intravenous micafungin 300 mg day is administered for 14 days.
Micafungin 150 mg Type of group
Micafungin 150 mg is administered once a day for 14 days.
Group name:micafungin 300 mg Type of group
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. The patient must have candidiasic esophagitis confimiada within 5 days prior to the administration of the first dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing patient. 2. Evidence of liver disease 3. Patients with another active opportunistic fungal infection and / or who receive acute systemic therapy for an opportunistic fungal infection. 4. Patients with concomitant esophagitis caused by herpes simplex virus or cytomegalovirus or other causes of irritant esophagitis that could interfere with the evaluation of clinical signs and symptoms. 5. Patients who received an oral, nonabsorbable (topical) antifungal agent within 48 hours, or a systemic antifungal agent within 72 hours prior to the initial dose of the study drug. 6. Patients that require an oral, nonabsorbable (topical) or systemic antifungal agent for a condition other than candidiasis esophagitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:clearing of esophageal lesions Measure:Comparative incidence of success, defined as complete clearing of esophageal lesions Timepoints:14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall therapeutic response Measure:Overall therapeutic response Timepoints:14 days | — |
Countries
Argentina, Brazil, Peru, South Africa
Outcome results
None listed