LeishmaniasisPKDLNCT05449717

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

An observational study of Leishmaniasis and Leishmaniasis, Visceral, run by Epicentre at 1 site in South Sudan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Leishmaniasis, Leishmaniasis, Visceral, Post-kala-azar Dermal Leishmaniasis
How many people: 52 participants
Where: 1 siteSouth Sudan
Study dates: 31 May 2022to 11 Apr 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Successfully treated and discharged primary cases of visceral leishmaniasis from the Médecins Sans Frontières-Operational Center Amsterdam (MSF-OCA)-run hospital in Jonglei State, South Sudan

Who may be able to join

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

Who cannot join

Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
Diagnosis of prior primary visceral leishmaniasis done only on clinical basis

Trial locations and contacts

1 site in 1 country.

South Sudan1 site

Lankien Hospital
Lankien, Jonglei

About this study

Official 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

Read the detailed description

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.

Conditions: Leishmaniasis, Leishmaniasis, Visceral, Post-kala-azar Dermal Leishmaniasis
Keywords: Leishmaniasis, Leishmaniasis, Visceral, Post-Kala-Azar Dermal Leishmaniasis, South Sudan, Kala-Azar
Medical subject headings: Leishmaniasis, Leishmaniasis, Visceral

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 12 months

Secondary outcomes (4)

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
Measured: 12 months
Characterize PKDL lesions
To characterize (e.g., grade, distribution) PKDL lesions
Measured: 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
Measured: 12 months
Rate and time period to self-healing of PKDL
To determine the rate and time period to self-healing of PKDL
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202211 Apr 2025

First posted8 Jul 2022
Study start31 May 2022
Primary completion11 Apr 2025
Study completion11 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LeishmaniasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05449717
Sponsor's protocol ID: PKDL/2184
Acronym: PKDL
Status last verified: Apr 2025
First submitted: 4 Jul 2022
Last updated: 24 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A long-standing individual participant data (IPD) sharing plan already exists between Epicentre and Médecins Sans Frontières.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Leishmaniasis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05449717
Acronym / sponsor ID: PKDL / PKDL/2184
Conditions: Leishmaniasis, Leishmaniasis, Visceral, Post-kala-azar Dermal Leishmaniasis
Keywords: Leishmaniasis, Leishmaniasis, Visceral, Post-Kala-Azar Dermal Leishmaniasis, South Sudan, Kala-Azar
Study type: Observational
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: EpicentreUniversity, hospital or other
Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP), Drugs for Neglected Diseases, Medecins Sans Frontieres, Netherlands
Study start: 31 May 2022 (actual)
Primary completion: 11 Apr 2025 (actual)
Study completion: 11 Apr 2025 (actual)
First posted: 8 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Successfully treated and discharged primary cases of visceral leishmaniasis from the Médecins Sans Frontières-Operational Center Amsterdam (MSF-OCA)-run hospital in Jonglei State, South Sudan

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
Diagnosis of prior primary visceral leishmaniasis done only on clinical basis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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

4 secondary outcomes

Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)
Time frame: 12 months
Characterize PKDL lesions
Time frame: 12 months
Risk factors for the development of VL relapse or PKDL
Time frame: 12 months
Rate and time period to self-healing of PKDL
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Individual participant dataSharing planned: Yes. A long-standing individual participant data (IPD) sharing plan already exists between Epicentre and Médecins Sans Frontières.

Related trials for Leishmaniasis

RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
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RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
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Not yet recruitingPhase 2
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca M Coulborn, MPH principal investigator

Epicentre

Margriet den Boer, MD principal investigator

Medecins Sans Frontieres, Netherlands

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Leishmaniasis and Leishmaniasis, Visceral, run by Epicentre at 1 site in South Sudan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of post-kala-azar-dermal leishmaniasis (PKDL) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05449717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.