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

NCT04699383 | Completed

• 1 other identifier: 1361/20
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient reported outcomes using the dermatology life quality index (DLQI)

  day 0 - day 180

• Side-effects

  day 0 - day 180

• Cycles to cure

  day 0 - day 180

• Factors associated with cure

  day 30, day 180

• Treatment outcome at day 30 (proportion with cure, good response, poor response, and no response )

  day 30

Interventions

Sodium Stibogluconate with allopurinol DRUG

Routine administration of SSG/allopurinol combination treatment, from 1-5 cycles

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Wollo University: collaborator
• Boru Meda Hospital: collaborator
• University of Gondar: collaborator

Study Sites (1)

Boru Meda Hospital

Dessie, Ethiopia

Location

Related 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. Trop Med Infect Dis. 2023 Aug 14;8(8):414. doi: 10.3390/tropicalmed8080414.

  PMID: 37624352 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

3mm Punch biopsy at baseline (optional), 4mL serum and 4 non-invasive tape sampling discs at every study visit (optional). Storage of routinely taken Giemsa-stained microscopy slide of skin slit smear sample

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Antimony Sodium Gluconate; Allopurinol

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: January 7, 2021
• Study Start: February 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)