Documentation of Patient Outcomes for SSG/Allopurinol Com... | NCT04699383

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

NCT04699383

Sponsor

Institute of Tropical Medicine, Belgium

Status

Completed

Last Update Posted

Mar 18, 2024Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Cutaneous Leishmaniasis

Interventions

Sodium Stibogluconate with allopurinol

Countries

Ethiopia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Dec 15, 2022Actual

Completion Date

Dec 15, 2022Actual

First Submitted Date

Oct 19, 2020

First Submission Date that Met QC Criteria

Jan 6, 2021

First Posted Date

Jan 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 18, 2024Actual

Name	Class
Wollo University	OTHER
Boru Meda Hospital	UNKNOWN
University of Gondar	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Stibogluconate with allopurinol	Drug	Routine administration of SSG/allopurinol combination treatment, from 1-5 cycles

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37624352	Result	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.

ID	Term
D007896	Leishmaniasis
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases

ID	Term
D000967	Antimony Sodium Gluconate
D000493	Allopurinol

ID	Term
D009930	Organic Chemicals
D005942	Gluconates
D013400	Sugar Acids
D000144	Acids, Acyclic