Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia

1361/20

Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated cutaneous leishmaniasis (CL) cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies. This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.

2021-02-15

2022-12-15

2022-12-15

Completed

105

Inclusion Criteria: * Clinically or microscopically confirmed diagnosis of MCL, DCL or complicated LCL * Clinical routine care decision to initiate systemic CL treatment using SSG with allopurinol * Willing and able to provide informed consent Exclusion Criteria: * Medical emergencies, underlying chronic conditions or other circumstances that make participation in this study medically or otherwise inadvisable Study sample collection only for Age 18 and above

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '3mm Punch biopsy at baseline (optional), 4mL serum and 4 non-invasive tape sampling discs at every study visit (optional).\n\nStorage of routinely taken Giemsa-stained microscopy slide of skin slit smear sample'}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2024-03-18