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Clinical trial

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

ID
Name
AmL Eld
Description
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).
Trial arms
Trial start
2019-03-01
Estimated PCD
2021-09-01
Trial end
2023-09-01
Status
Completed
Phase
Early phase I
Treatment
Liposomal amphotericin B (AmBisome®)
Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
Arms:
Group Anfo12mg/kg, Group Anfo18mg/kg, Group Anfo24mg/kg
Size
28
Primary endpoint
Total initial cicatrization
30 to 90 days after the first day of treatment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}
Updated at
2024-06-07

1 organization

1 product

2 indications

Organization
Hospital Universitário Professor Edgard Santos
Product
Liposomal amphotericin B
Indication
Cutaneous Leishmaniasis
Indication
Native American myxoid fibrosarcoma