Incidence of Relapse and Post-Kala-Azar Dermal Leishmania... | NCT05449717

Studies
Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan

NCT05449717

Sponsor

Epicentre

Status

Completed

Last Update Posted

Apr 24, 2025Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Leishmaniasis
Leishmaniasis, Visceral
Post-kala-azar Dermal Leishmaniasis

Interventions

Not provided

Countries

South Sudan

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

Apr 2025

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

May 31, 2022Actual

Primary Completion Date

Apr 11, 2025Actual

Completion Date

Apr 11, 2025Actual

First Submitted Date

Jul 4, 2022

First Submission Date that Met QC Criteria

Jul 4, 2022

First Posted Date

Jul 8, 2022Actual

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

Apr 22, 2025

Last Update Posted Date

Apr 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

EpicentreOTHER

Collaborators

Name	Class
European and Developing Countries Clinical Trials Partnership (EDCTP)	OTHER_GOV
Drugs for Neglected Diseases	OTHER
Medecins Sans Frontieres, Netherlands	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

This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.

Detailed Description

This prospective, observational cohort study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis from a hospital in Lankien, South Sudan.

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

No data available

No data is available for this block.

Enrollment

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-kala-azar-dermal leishmaniasis (PKDL)	To determine the incidence of PDKL after initial successful treatment of primary visceral leishmaniasis (VL) over a period of 12 months	12 months
Incidence of VL relapse	To determine the incidence of VL relapse after initial successful treatment of primary VL over a period of 12 months	12 months

Secondary Outcomes

Measure	Description	Time Frame
Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)	To determine the time of onset of VL relapse or PKDL at follow-up 1, 3, 6, 9, and 12 months after initial successful treatment of primary VL	12 months
Characterize PKDL lesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary visceral leishmaniasis patients who had a confirmed (serological and/or parasitological) diagnosis at admission, and who were discharged after successful treatment
Availability for follow up visits
Provision of informed consent, and in the case of minors 12 to 17 years of age, assent as well

Exclusion Criteria:

Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
Diagnosis of prior primary visceral leishmaniasis done only on clinical basis

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

Successfully treated and discharged primary cases of visceral leishmaniasis from the Médecins Sans Frontières-Operational Center Amsterdam (MSF-OCA)-run hospital in Jonglei State, South Sudan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca M Coulborn, MPH	Epicentre	Principal Investigator
Margriet den Boer, MD	Medecins Sans Frontieres, Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lankien Hospital		Lankien	Jonglei		South Sudan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

A long-standing individual participant data (IPD) sharing plan already exists between Epicentre and Médecins Sans Frontières.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

The data will be shared as they become available, for the duration of the project, estimated at 3 years.

Access Criteria

Existing co-investigator, or permission of Co-Principal Investigators, on research protocol.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007896	Leishmaniasis
D007898	Leishmaniasis, Visceral

Ancestor Terms

ID	Term
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided