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

A Prospective Cohort Study on the Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis After Treatment for Primary Visceral Leishmaniasis in South Sudan

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.

Study Overview

• Status: Recruiting
• Conditions: Leishmaniasis; Leishmaniasis, Visceral; Post-kala-azar Dermal 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.

• Study Type: Observational
• Enrollment (Estimated): 367

Contacts and Locations

• Study Contact: Name: Rebecca M Coulborn, MPH; Phone Number: +33 1 40 21 55 55; Email: rebecca.coulborn@epicentre.msf.org
• Study Contact Backup: Name: Etienne Gignoux, PhD; Phone Number: +41 22 849 84 84; Email: Etienne.gignoux@geneva.msf.org

Study Locations

• South Sudan
  • Jonglei
    • Lankien, Jonglei, South Sudan
      • Recruiting
      • Lankien Hospital
      • Contact: Margriet den Boer, MD; Phone Number: +44 20 7404 6600; Email: Margriet.den.boer@london.msf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	To characterize (e.g., grade, distribution) PKDL lesions	12 months
Risk factors for the development of VL relapse or PKDL	To assess the risk factors for the development of VL relapse or PKDL after initial successful treatment of primary VL	12 months
Rate and time period to self-healing of PKDL	To determine the rate and time period to self-healing of PKDL	12 months

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Drugs for Neglected Diseases; European and Developing Countries Clinical Trials Partnership (EDCTP); Medecins Sans Frontieres, Netherlands
• Investigators: Principal Investigator: Rebecca M Coulborn, MPH, Epicentre; Principal Investigator: Margriet den Boer, MD, Medecins Sans Frontieres, Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Leishmaniasis; Leishmaniasis, Visceral; Post-Kala-Azar Dermal Leishmaniasis; South Sudan; Kala-Azar
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Visceral
• Other Study ID Numbers: PKDL/2184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A long-standing individual participant data (IPD) sharing plan already exists between Epicentre and Médecins Sans Frontières.
• IPD Sharing Time Frame: The data will be shared as they become available, for the duration of the project, estimated at 3 years.
• IPD Sharing Access Criteria: Existing co-investigator, or permission of Co-Principal Investigators, on research protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No