A Multicentre Observational Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Parasite load in skin
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Patients
Patients who have a diagnosis of visceral leishmaniasis and will be treated with SSG/PM
Intervention: Sodium stibogluconate / paramomycin (Drug)
Outcomes
Primary Outcomes
Parasite load in skin
Time Frame: 36 months
Identification of parasite load in skin biopsies from patients with VL
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.
Secondary Outcomes
- Parasite genotype(36 months)
- Immunological and parasitological data across sites(36 months)
Investigators
Paul Kaye
Professor of Immunology
University of York