drugset / Trial / NCT06449040
Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly
Phase 1/2
Completed
28 enrolled
Hospital Universitário Professor Edgard Santos
Instituto Gonçalo Muniz FIOCRUZ BA · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).
Timeline
- Start
- 2019-03-01
- Primary completion
- 2021-09-01
- Completion
- 2023-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amphotericin B | Unknown | 12 mg/kg | Intravenous |
| Comparator | Amphotericin B | Unknown | 18 mg/kg | Intravenous |
| Comparator | Amphotericin B | Unknown | 24 mg/kg | Intravenous |