drugset / Trial / NCT01562132
Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection
Phase 2
Terminated
6 enrolled
Yale University
Bausch Health Americas, Inc. · collabKenya Medical Research Institute · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabUniversity of Nairobi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if treatment with two medicines in combination (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for the treatment of an early infection with a fungus called cryptococcus.
Timeline
- Start
- 2013-09
- Primary completion
- 2014-07
- Completion
- 2014-07
Outcome
Outcome not reported
Stopped (Enrollment): “Stopped in accordance with pre-specified stopping rules for poor recruitment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluconazole | Small molecule | 200 mg | Oral |
| Subject | Flucytosine | Small molecule | 100 mg/kg | Oral |