Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

Cutaneous Leishmaniasis, American Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06449040
• Other study ID #: AmL Eld
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2024
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis, American
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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

Locations

Country	Name	City	State
Brazil	Corte de Pedra Health Post	Presidente Tancredo Neves	BA

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos	Instituto Gonçalo Muniz FIOCRUZ BA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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