Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly: a Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Cutaneous Leishmaniasis, American
• Intervention / Treatment: Drug: Liposomal amphotericin B (AmBisome®)

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Presidente Tancredo Neves, BA, Brazil, 40000
      • Corte de Pedra Health Post

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Anfo12mg/kg; Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg	Drug: Liposomal amphotericin B (AmBisome®); Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
Active Comparator: Group Anfo18mg/kg; Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg	Drug: Liposomal amphotericin B (AmBisome®); Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
Active Comparator: Group Anfo24mg/kg; Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg	Drug: Liposomal amphotericin B (AmBisome®); Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total initial cicatrization	Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation	30 to 90 days after the first day of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total final cicatrization	Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation	30 to 180 days after the first day of treatment
Time to cure	Number of days from the first day of treatment until total ulcer cicatrization	30 to 180 days after the first day of treatment

Collaborators and Investigators

• Sponsor: Hospital Universitário Professor Edgard Santos
• Collaborators: Instituto Gonçalo Muniz FIOCRUZ BA
• Investigators: Principal Investigator: PAULO MACHADO, MD, PhD, Federal University of Bahia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Cutaneous Leishmaniasis; L. braziliensis; Liposomal Amphotericn B
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; Amphotericin B; Liposomal amphotericin B
• Other Study ID Numbers: AmL Eld

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No