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

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.

Primary outcomes

• 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 outcomes

• 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

Sex: All

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

• Rebecca M Coulborn, MPH, Principal investigator, Epicentre
• Margriet den Boer, MD, Principal investigator, Medecins Sans Frontieres, Netherlands