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

NCT ID: NCT05449717

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2025-04-11

Brief Summary

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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

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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.

Conditions

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Leishmaniasis Leishmaniasis, Visceral Post-kala-azar Dermal Leishmaniasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

Drugs for Neglected Diseases

OTHER

Sponsor Role collaborator

Medecins Sans Frontieres, Netherlands

OTHER

Sponsor Role collaborator

Epicentre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca M Coulborn, MPH

Role: PRINCIPAL_INVESTIGATOR

Epicentre

Margriet den Boer, MD

Role: PRINCIPAL_INVESTIGATOR

Medecins Sans Frontieres, Netherlands

Locations

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Lankien Hospital

Lankien, Jonglei, South Sudan

Site Status

Countries

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South Sudan

Other Identifiers

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PKDL/2184

Identifier Type: -

Identifier Source: org_study_id

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