Leishmaniasis Clinical Trial
— PKDLOfficial 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
NCT number | NCT05449717 |
Other study ID # | PKDL/2184 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2022 |
Est. completion date | May 31, 2026 |
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.
Status | Recruiting |
Enrollment | 367 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
South Sudan | Lankien Hospital | Lankien | Jonglei |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Drugs for Neglected Diseases, European and Developing Countries Clinical Trials Partnership (EDCTP), Medecins Sans Frontieres, Netherlands |
South Sudan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Characterize PKDL lesions | To characterize (e.g., grade, distribution) PKDL lesions | 12 months | |
Secondary | 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 | |
Secondary | Rate and time period to self-healing of PKDL | To determine the rate and time period to self-healing of PKDL | 12 months |
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