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

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

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Leishmaniasis
• Intervention / Treatment: Drug: Sodium Stibogluconate with allopurinol

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 Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Ethiopia
  • Dessie, Ethiopia
    • Boru Meda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: University of Gondar; Wollo University; Boru Meda Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Free Radical Scavengers; Anthelmintics; Gout Suppressants; Schistosomicides; Antiplatyhelmintic Agents; Allopurinol; Antimony Sodium Gluconate
• Other Study ID Numbers: 1361/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No