Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse) [day 180]
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
Secondary Outcome Measures
- Patient reported outcomes using the dermatology life quality index (DLQI) [day 0 - day 180]
Mean difference in Dermatology life quality index (min 0, max 30) before treatment and at day 180
- Side-effects [day 0 - day 180]
Proportion of patients with side-effects and proportion of side-effects according to CTCAE severity grades
- Cycles to cure [day 0 - day 180]
Number of cycles needed to reach cure
- Factors associated with cure [day 30, day 180]
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
- Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response ) [day 30]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinically or microscopically confirmed diagnosis of MCL, DCL or complicated LCL
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Clinical routine care decision to initiate systemic CL treatment using SSG with allopurinol
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boru Meda Hospital | Dessie | Ethiopia |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
- Wollo University
- Boru Meda Hospital
- University of Gondar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1361/20