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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05449717

Acronym

PKDL

Enrollment

Registered

2022-07-08

Start date

2022-05-31

Completion date

2025-04-11

Last updated

2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Sudan

Outcome results