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.
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
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Drugs for Neglected Diseases, Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
- Investigators
- Rebecca M Coulborn, MPH, Principal investigator, EpicentreMargriet den Boer, MD, Principal investigator, Medecins Sans Frontieres, Netherlands
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.
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
- 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.
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.
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.
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.
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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?
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.