Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Sodium Stibogluconate with allopurinol

Study type: Observational

Funder types: Other

Identifiers

NCT04699383

1361/20

Details and patient eligibility

About

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.

Full description

Cutaneous Leishmaniasis (CL) in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are complicated localized cutaneous leishmaniasis (cLCL), mucocutaneous leishmaniasis (MCL), and diffuse cutaneous leishmaniasis (DCL). The clinical presentation of CL depends on various factors including parasite species, infection history and differences in the immune response. National guidelines recommend equally all drugs that are also used for visceral leishmaniasis treatment. Sodium stibogluconate (SSG) is one of these recommended medications. However, dermatologists in Ethiopia also use a combination of SSG and Allopurinol for treatment of complicated cutaneous leishmaniasis.

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 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.

Enrollment: 105 patients

Sex: All

Volunteers: No Healthy Volunteers

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