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Completed

NCT Number: NCT05449717

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

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.

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Key information

Conditions

Leishmaniasis Euglenozoa Infections Infections Leishmaniasis, Visceral Parasitic Diseases Post-kala-azar Dermal Leishmaniasis Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Lankien Hospital

Lankien, Jonglei, South Sudan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of post-kala-azar-dermal leishmaniasis (PKDL)

    Time frame: 12 months

    To determine the incidence of PDKL after initial successful treatment of primary visceral leishmaniasis (VL) over a period of 12 months

  2. Incidence of VL relapse

    Time frame: 12 months

    To determine the incidence of VL relapse after initial successful treatment of primary VL over a period of 12 months

Secondary outcomes

  1. Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)

    Time frame: 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

  2. Characterize PKDL lesions

    Time frame: 12 months

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

  3. Risk factors for the development of VL relapse or PKDL

    Time frame: 12 months

    To assess the risk factors for the development of VL relapse or PKDL after initial successful treatment of primary VL

  4. Rate and time period to self-healing of PKDL

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Drugs for Neglected Diseases
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Medecins Sans Frontieres, Netherlands

Registry information

Official study title

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

Acronym: PKDL

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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