Clinical trial NCT06449040: Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly
Official title: Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cutaneous Leishmaniasis, American
Keywords: Cutaneous Leishmaniasis
Liposomal Amphotericn B
L. braziliensis
Elderly
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Instituto Gonçalo Muniz FIOCRUZ BA
First posted: 2024-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total initial cicatrization
timeFrame: 30 to 90 days after the first day of treatment
Secondary outcomes:
measure: Total final cicatrization
timeFrame: 30 to 180 days after the first day of treatment
measure: Time to cure
timeFrame: 30 to 180 days after the first day of treatment
Other outcomes:
Locations:
city: Presidente Tancredo Neves
country: Brazil
facility: Corte de Pedra Health Post
state: BA
Study officials:
affiliation: Federal University of Bahia
name: PAULO MACHADO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: