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

Epicentre52 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Leishmaniasis Leishmaniasis, Visceral Post-kala-azar Dermal Leishmaniasis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Lankien Hospital

Lankien, Jonglei, South Sudan

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Characterize PKDL lesions

To characterize (e.g., grade, distribution) PKDL lesions

Time frame: 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

Time frame: 12 months

Rate and time period to self-healing of PKDL

To determine the rate and time period to self-healing of PKDL

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.