Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

NCT06449040 | Completed Phase 1

• 1 other identifier: AmL Eld
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Cutaneous Leishmaniasis, American

Keywords

Cutaneous Leishmaniasis; Liposomal Amphotericn B; L. braziliensis; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total final cicatrization

  30 to 180 days after the first day of treatment

• Time to cure

  30 to 180 days after the first day of treatment

Study Arms (3)

Group Anfo12mg/kg

ACTIVE COMPARATOR

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

Drug: Liposomal amphotericin B (AmBisome®)

Group Anfo18mg/kg

ACTIVE COMPARATOR

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

Drug: Liposomal amphotericin B (AmBisome®)

Group Anfo24mg/kg

ACTIVE COMPARATOR

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

Drug: Liposomal amphotericin B (AmBisome®)

Interventions

Liposomal amphotericin B (AmBisome®) DRUG

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

Group Anfo12mg/kg; Group Anfo18mg/kg; Group Anfo24mg/kg

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous CL treatment
• Renal or hepatic disease
• HIV co-infection.

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead
• Instituto Gonçalo Muniz FIOCRUZ BA: collaborator

Study Sites (1)

Corte de Pedra Health Post

Presidente Tancredo Neves, Estado de Bahia, 40000, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis, Mucocutaneous; Leishmaniasis, Cutaneous

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• PAULO MACHADO, MD, PhD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Immunology Service

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: March 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)