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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Sodium Stibogluconate with allopurinol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sodium Stibogluconate with allopurinol|Routine administration of SSG/allopurinol combination treatment, from 1-5 cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse) | cure defined as 100% flattening and/or reepithelization, good response 50-99% flattening and/or reepithelization, poor response 1-49% flattening and/or reepithelization, no response 0% flattening and/or reepithelization and relapse as worsening of existing lesion or appearance of new lesions | day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes using the dermatology life quality index (DLQI) | Mean difference in Dermatology life quality index (min 0, max 30) before treatment and at day 180 | day 0 - day 180 | 
| Side-effects | Proportion of patients with side-effects and proportion of side-effects according to CTCAE severity grades | day 0 - day 180 | 
| Cycles to cure | Number of cycles needed to reach cure | day 0 - day 180 | 
| Factors associated with cure | To determine covariate-adjusted risk ratios for baseline and follow-up factors associated with cure after one cycle of treatment and at the end of cycle 5 | day 30, day 180 | 
| Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response ) | cure defined as 100% flattening and/or reepithelization, good response 50-99% flattening and/or reepithelization, poor response 1-49% flattening and/or reepithelization, no response 0% flattening and/or reepithelization | day 30 |