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

Recruiting

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

• Registration Number: NCT05449717
• Lead Sponsor: Epicentre

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.

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 367

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Characterize PKDL lesions	12 months	To characterize (e.g., grade, distribution) PKDL lesions
Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)	12 months	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
Rate and time period to self-healing of PKDL	12 months	To determine the rate and time period to self-healing of PKDL
Risk factors for the development of VL relapse or PKDL	12 months	To assess the risk factors for the development of VL relapse or PKDL after initial successful treatment of primary VL

Trial Locations

Locations (1)

Lankien Hospital; 🇸🇸 Lankien, Jonglei, South Sudan