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

Leishmaniasis Clinical Trial

— PKDL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449717
• Other study ID #: PKDL/2184
• Status: Recruiting
• Start date: May 31, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: September 2023
• Source: Epicentre
• Contact: Rebecca M Coulborn, MPH
• Phone: +33 1 40 21 55 55
• Email: rebecca.coulborn[@]epicentre.msf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 367
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
South Sudan	Lankien Hospital	Lankien	Jonglei

Sponsors (4)

Lead Sponsor	Collaborator
Epicentre	Drugs for Neglected Diseases, European and Developing Countries Clinical Trials Partnership (EDCTP), Medecins Sans Frontieres, Netherlands

Country where clinical trial is conducted

South Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Characterize PKDL lesions	To characterize (e.g., grade, distribution) PKDL lesions	12 months
Secondary	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
Secondary	Rate and time period to self-healing of PKDL	To determine the rate and time period to self-healing of PKDL	12 months