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

Cutaneous Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699383
• Other study ID #: 1361/20
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2024
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Boru Meda Hospital	Dessie

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Boru Meda Hospital, University of Gondar, Wollo University

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Side-effects	Proportion of patients with side-effects and proportion of side-effects according to CTCAE severity grades	day 0 - day 180
Secondary	Cycles to cure	Number of cycles needed to reach cure	day 0 - day 180
Secondary	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
Secondary	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