Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cutaneous Leishmaniasis, American

Treatments: Drug: Liposomal amphotericin B (AmBisome®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06449040

AmL Eld

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 3 patient groups

Group Anfo12mg/kg

Active Comparator group

Description:

Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg

Treatment:

Drug: Liposomal amphotericin B (AmBisome®)

Group Anfo18mg/kg

Active Comparator group

Description:

Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg

Treatment:

Drug: Liposomal amphotericin B (AmBisome®)

Group Anfo24mg/kg

Active Comparator group

Description:

Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg

Treatment:

Drug: Liposomal amphotericin B (AmBisome®)