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

Study Overview
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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.

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

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

Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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South Sudan, Leishmaniasis, Leishmaniasis, Visceral, Post-Kala-Azar Dermal Leishmaniasis, Kala-Azar