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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05449717
Other study ID # PKDL/2184
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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