Cutaneous Leishmaniasis, American
Conditions
Keywords
Cutaneous Leishmaniasis, Liposomal Amphotericn B, L. braziliensis, Elderly
Brief 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).
Detailed description
The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups. The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.
Interventions
Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
Sponsors
Instituto Gonçalo Muniz FIOCRUZ BA
Hospital Universitário Professor Edgard Santos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CL clinical diagnosis (presence of an ulcer) * CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border * Presence of one to a maximum of three ulcers * Ulcer size between 1 and 5 mm * Ulcer evolution of 1 to 6 months
Exclusion criteria
* Previous CL treatment * Renal or hepatic disease * HIV co-infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total initial cicatrization | 30 to 90 days after the first day of treatment | Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total final cicatrization | 30 to 180 days after the first day of treatment | Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation |
| Time to cure | 30 to 180 days after the first day of treatment | Number of days from the first day of treatment until total ulcer cicatrization |
Countries
Brazil
Outcome results
None listed