Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-09-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cutaneous Leishmaniasis, American

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Anfo12mg/kg

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

Group Type ACTIVE_COMPARATOR

Liposomal amphotericin B (AmBisome®)

Intervention Type DRUG

Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved

Group Anfo18mg/kg

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

Group Type ACTIVE_COMPARATOR

Liposomal amphotericin B (AmBisome®)

Intervention Type DRUG

Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved

Group Anfo24mg/kg

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

Group Type ACTIVE_COMPARATOR

Liposomal amphotericin B (AmBisome®)

Intervention Type DRUG

Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved

Interventions

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Liposomal amphotericin B (AmBisome®)

Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved

Intervention Type DRUG

Eligibility Criteria

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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