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

Sponsor

Epicentre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05449717

Collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP) (Other), Drugs for Neglected Diseases (Other), Medecins Sans Frontieres, Netherlands (Other)

367

Enrollment

Location

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

367 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2025

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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