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

NCT05449717 | Completed

• 1 other identifier: PKDL/2184
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis; Leishmaniasis, Visceral; Post-kala-azar Dermal Leishmaniasis

Keywords

Leishmaniasis; Leishmaniasis, Visceral; Post-Kala-Azar Dermal Leishmaniasis; South Sudan; Kala-Azar

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)

  12 months

• Characterize PKDL lesions

  12 months

• Risk factors for the development of VL relapse or PKDL

  12 months

• Rate and time period to self-healing of PKDL

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Epicentre: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Drugs for Neglected Diseases: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (1)

Lankien Hospital

Lankien, Jonglei, South Sudan

Location

MeSH Terms

Conditions

Leishmaniasis; Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

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

Study Officials

• Rebecca M Coulborn, MPH

  Epicentre

  PRINCIPAL INVESTIGATOR

• Margriet den Boer, MD

  Medecins Sans Frontieres, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: May 31, 2022
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.

Locations

SO (1)