None listed
Conditions
Interventions
50mg/dia de FK463 Type of group
The study medication will be administered once a day in the form of an intravenous infusion of 100 ml for one hour.
Group name:200mg / day of fluconazole Type of group
The study medication will be administered once a day in the form of an intravenous infusion of 100 ml for one hour.
Sponsors
FUJISAWAGMBH (ALEMANIA),
Eligibility
Inclusion criteria
Inclusion criteria: The patient must have candidiasis esophagitis, with or without involvement of the oropharyngeal area, without typical signs, documented clinical symptoms and confirmed by endoscopy. A histological / cytological confirmation should be obtained by brushing and esophageal biopsy, the results of which may still be pending at the moment of enrolling the patient. Patient of both sexes older than 18 years. The patient should have veins that are sufficiently accessible to allow medication to be administered.
Exclusion criteria
Exclusion criteria: Evidence of liver disease. Pregnant or breast-feeding patient. Patient with significant renal disease. Patient with another opportunistic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:clinical evaluation, microbiological response, clinical response and relapse evaluation. Measure:grade 0 endoscopic evaluation at the end of therapy Timepoints:14 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serious adverse effects, vital signs and clinically significant changes were evaluated. Measure:safety evaluation Timepoints:14 day | — |
Countries
Brazil, Peru, South Africa, United Kindgdom
Outcome results
None listed