Clinical trial NCT04699383: Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
Official title: Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Wollo University
name: Boru Meda Hospital
name: University of Gondar
First posted: 2021-01-07
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cLCL, MCL, or DCL who present during the study period, either referred from peripheral facilities or self-referred, and who receive systemic CL treatment using SSG and allopurinol will be invited to be included in the study consecutively. The decision whether or not to use SSG and Allopurinol in a patient is part of routine care.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse)
timeFrame: day 180
Secondary outcomes:
measure: Patient reported outcomes using the dermatology life quality index (DLQI)
timeFrame: day 0 - day 180
measure: Side-effects
timeFrame: day 0 - day 180
measure: Cycles to cure
timeFrame: day 0 - day 180
measure: Factors associated with cure
timeFrame: day 30, day 180
measure: Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response )
timeFrame: day 30
Other outcomes:
Locations:
city: Dessie
country: Ethiopia
facility: Boru Meda Hospital
Study officials:
References:
citation: van Henten S, Bialfew F, Hassen S, Tilahun F, van Griensven J, Abdela SG. Treatment of Cutaneous Leishmaniasis with Sodium Stibogluconate and Allopurinol in a Routine Setting in Ethiopia: Clinical and Patient-Reported Outcomes and Operational Challenges. Trop Med Infect Dis. 2023 Aug 14;8(8):414. doi: 10.3390/tropicalmed8080414.