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NCT Number: NCT04699383

Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Boru Meda Hospital

Dessie, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Stibogluconate with allopurinol

Drug

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

Primary outcomes

  1. Treatment outcome at day 180 (proportion with cure, good response, poor response, no response and relapse)

    Time frame: 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 outcomes

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

    Time frame: day 0 - day 180

    Mean difference in Dermatology life quality index (min 0, max 30) before treatment and at day 180

  2. Side-effects

    Time frame: day 0 - day 180

    Proportion of patients with side-effects and proportion of side-effects according to CTCAE severity grades

  3. Cycles to cure

    Time frame: day 0 - day 180

    Number of cycles needed to reach cure

  4. Factors associated with cure

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Boru Meda Hospital
  • University of Gondar
  • Wollo University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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