Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis
- Conditions
- -B37 CandidiasisCandidiasisB37
- Registration Number
- PER-026-04
- Lead Sponsor
- FUJISAWA HEALTH CARE INC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:clearing of esophageal lesions<br>Measure:Comparative incidence of success, defined as complete clearing of esophageal lesions<br>Timepoints:14 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Overall therapeutic response<br>Measure:Overall therapeutic response<br>Timepoints:14 days<br>