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Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

NCT06449040 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-06-07

No results posted yet for this study

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

Interventions

DRUG

Liposomal amphotericin B (AmBisome®)

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

Sponsors & Collaborators

  • Instituto Gonçalo Muniz FIOCRUZ BA

    collaborator UNKNOWN

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • PAULO MACHADO, MD, PhD · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-09-01
Completion
2023-09-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449040 on ClinicalTrials.gov