Visceral LeishmaniasisNCT04342715
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
An observational study of Visceral Leishmaniasis, run by University of York at 1 site in Kenya.
Trial summary
ImmStat@Cure is a multicentre observational study designed to assess the immune status of patients before and after treatment for visceral leishmaniasis. Forty patients and 30 controls will be recruited per site. The follow-up period is 6 months from the end of treatment. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Sodium stibogluconate / paramomycin
- How many people
- 216 participants
- Where
- 1 siteKenya
- Study dates
- 22 May 2022to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with a confirmed diagnosis of VL and judged suitable for standard treatment regimen of SSG/PM.Patients will be recruited by active case detection. Controls will be recruited using convenient sampling method.
Who may be able to join
- Aged 12 to 50 years on the day of diagnosis
- Have confirmed diagnosis of VL and be judged suitable for treatment using a standard regimen of SSG/PM
- Willing and able to give written informed consent
- For adolescents aged 12 to 17 years on the day of screening, written informed consent from a parent must be obtained in addition to assent from the patient
- Without any other significant health problems as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator
- Negative for malaria on blood smear
- Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol
Who cannot join
- The patient may not enter the study if any of the following apply:
- Has HIV, HBV or HBC
- Has previously had any form of leishmaniasis
- Pregnancy or lactating mothers
- Any confirmed or suspected immunosuppressive or immunodeficient state, including; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
- Tuberculosis, leprosy, or severe malnutrition (severe malnutrition in adults defined as a BMI <18.5, and in adolescents (12-17yrs) as a Z score cut-off value of <-2 SD)
- Any other significant disease, disorder or finding, which, in the opinion of a medically qualified Clinical Investigator, may influence the result of the study, or the volunteer's ability to participate in the study
- Unlikely to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Observational Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
ImmStat@Cure is a multicentre observational study designed to assess the immune status of patients before and after treatment for visceral leishmaniasis. Forty patients and 30 controls will be recruited per site. The follow-up period is 6 months from the end of treatment.
Read the detailed description
ImmStat@Cure will be undertaken at 4 treatment centres for leishmaniasis in East Africa; the Institute for Endemic Diseases, University of Khartoum, Khartoum, Sudan, the University of Gondar, Gondar, Ethiopia, Amudat Hospital, Amudat, Uganda and the Kimalel and Chemolingot Health Centres, Baringo County, Kenya.
The primary objective of the study is to assess systemic and skin immune responses and parasite load in patients before, and at end of treatment for visceral leishmaniasis.
Secondary objectives are:
- To identify systemic and local immune correlates of treatment outcome
- To evaluate parasite genotype in relation to immune response characteristics
- To compare immunological and parasitological data across each site and determine possible correlates of progression to PKDL
The outcomes include data on immune cell phenotypes and function in peripheral blood and tissue, as determined using standard methods in immunology (e.g. flow cytometry, transcriptomics and histopathology) and parasite quantitation (e.g. PCR, histopathology). There will be qualitative and quantitative analysis of data across patient cohorts and between patients and controls.
Forty patients diagnosed with VL from each site will be included in the study. Patients must be willing and able to adhere to the study procedures and to give written informed consent. All patients will have been clinically and parasitologically confirmed as having visceral leishmaniasis (VL) and will receive one round of sodium stibgluconate/paramomycin (SSG/PM) treatment as per normal clinical practice and regional guidelines. Thirty healthy endemic controls will also be studied from each country.
For patients, confirmation of VL will be made by visual identification of parasites in stained tissue smears according to recommended diagnostic practice (using bone marrow, spleen or lymph node aspirates as clinically indicated and as per local procedures). Parasites will be isolated from residual tissue aspirate and genotyped. Where tissue aspirate is not a recommended or currently performed diagnostic procedure, parasites will be isolated where possible from blood and diagnosis confirmed by PCR.
The study requires two additional blood draws, one taken before treatment and the second taken at the end of treatment.
The study also requires two 3mm skin biopsies (taken from the back of the neck/shoulder), one taken prior to the beginning of treatment and the second taken at the end of treatment. Biopsies will be taken under local anaesthesia. Patients refusing skin biopsies can still be recruited into the study.
For healthy controls, 23mL of blood will be taken on a single occasion, for diagnostic purposes and to provide blood for immunological analyses.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Sodium stibogluconate / paramomycin
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium stibogluconate / paramomycinDrug
Treatment with Sodium stibogluconate / paramomycin
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have a diagnosis of visceral leishmaniasis and will be treated with SSG/PM Receives: Drug: Sodium stibogluconate / paramomycin | |
| Control | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cell phenotypes present in peripheral blood and tissue
Identification of immune cell phenotypes present in peripheral blood and tissue before and after treatment for VL.
Measured: 36 months
Parasite load in skin
Identification of parasite load in skin biopsies from patients with VL
Measured: 36 months
Secondary outcomes (2)
Parasite genotype
Evaluate parasite genotype in relation to immune response characteristics
Measured: 36 months
Immunological and parasitological data across sites
To compare immunological and parasitological data across and between sites and determine possible correlates of progression to PKDL.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start22 May 2022
- Primary completion31 May 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, Kenya Medical Research Institute, Makerere University, University of Khartoum, European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Principal investigator, Paul Kaye, University of York
- Investigators
- Paul Kaye, PhD, Study director, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342715
- Sponsor's protocol ID
- ImmStat@Cure (PK202001)
- Other IDs
- RIA2016V-1640
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2020
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT04342715
- Acronym / sponsor ID
- ImmStat@Cure (PK202001)
- Conditions
- Visceral Leishmaniasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Collaborators
- University of Gondar, Kenya Medical Research Institute, Makerere University, University of Khartoum, European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 22 May 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Apr 2020 (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.
ImmStat@Cure is a multicentre observational study designed to assess the immune status of patients before and after treatment for visceral leishmaniasis. Forty patients and 30 controls will be recruited per site. The follow-up period is 6 months from the end of treatment.
Detailed description
ImmStat@Cure will be undertaken at 4 treatment centres for leishmaniasis in East Africa; the Institute for Endemic Diseases, University of Khartoum, Khartoum, Sudan, the University of Gondar, Gondar, Ethiopia, Amudat Hospital, Amudat, Uganda and the Kimalel and Chemolingot Health Centres, Baringo County, Kenya.
The primary objective of the study is to assess systemic and skin immune responses and parasite load in patients before, and at end of treatment for visceral leishmaniasis.
Secondary objectives are:
- To identify systemic and local immune correlates of treatment outcome
- To evaluate parasite genotype in relation to immune response characteristics
- To compare immunological and parasitological data across each site and determine possible correlates of progression to PKDL
The outcomes include data on immune cell phenotypes and function in peripheral blood and tissue, as determined using standard methods in immunology (e.g. flow cytometry, transcriptomics and histopathology) and parasite quantitation (e.g. PCR, histopathology). There will be qualitative and quantitative analysis of data across patient cohorts and between patients and controls.
Forty patients diagnosed with VL from each site will be included in the study. Patients must be willing and able to adhere to the study procedures and to give written informed consent. All patients will have been clinically and parasitologically confirmed as having visceral leishmaniasis (VL) and will receive one round of sodium stibgluconate/paramomycin (SSG/PM) treatment as per normal clinical practice and regional guidelines. Thirty healthy endemic controls will also be studied from each country.
For patients, confirmation of VL will be made by visual identification of parasites in stained tissue smears according to recommended diagnostic practice (using bone marrow, spleen or lymph node aspirates as clinically indicated and as per local procedures). Parasites will be isolated from residual tissue aspirate and genotyped. Where tissue aspirate is not a recommended or currently performed diagnostic procedure, parasites will be isolated where possible from blood and diagnosis confirmed by PCR.
The study requires two additional blood draws, one taken before treatment and the second taken at the end of treatment.
The study also requires two 3mm skin biopsies (taken from the back of the neck/shoulder), one taken prior to the beginning of treatment and the second taken at the end of treatment. Biopsies will be taken under local anaesthesia. Patients refusing skin biopsies can still be recruited into the study.
For healthy controls, 23mL of blood will be taken on a single occasion, for diagnostic purposes and to provide blood for immunological analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Sodium stibogluconate / paramomycinPatients who have a diagnosis of visceral leishmaniasis and will be treated with SSG/PM |
| Control | – | –Healthy volunteers |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with a confirmed diagnosis of VL and judged suitable for standard treatment regimen of SSG/PM.Patients will be recruited by active case detection. Controls will be recruited using convenient sampling method.
Key inclusion criteria (7 listed)
- Aged 12 to 50 years on the day of diagnosis
- Have confirmed diagnosis of VL and be judged suitable for treatment using a standard regimen of SSG/PM
- Willing and able to give written informed consent
- For adolescents aged 12 to 17 years on the day of screening, written informed consent from a parent must be obtained in addition to assent from the patient
- Without any other significant health problems as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator
Key exclusion criteria (8 listed)
- Has HIV, HBV or HBC
- Has previously had any form of leishmaniasis
- Pregnancy or lactating mothers
- Any confirmed or suspected immunosuppressive or immunodeficient state, including; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
- Tuberculosis, leprosy, or severe malnutrition (severe malnutrition in adults defined as a BMI <18.5, and in adolescents (12-17yrs) as a Z score cut-off value of <-2 SD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium stibogluconate / paramomycinTreatment with Sodium stibogluconate / paramomycin | Drug | Patients |
Primary outcome
Immune cell phenotypes present in peripheral blood and tissue
Time frame: 36 months
Identification of immune cell phenotypes present in peripheral blood and tissue before and after treatment for VL.
Parasite load in skin
Time frame: 36 months
Identification of parasite load in skin biopsies from patients with VL
2 secondary outcomes
Parasite genotype
Time frame: 36 months
Immunological and parasitological data across sites
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Paul Kaye, PhD study director
University of York
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 Visceral Leishmaniasis, run by University of York at 1 site in Kenya.
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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 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 Kenya. 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?
This study is still under way. Results are not available in the source record yet.
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?
Immune cell phenotypes present in peripheral blood and tissue (time frame: 36 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 Jul 2025.