Visceral Leishmaniasis Clinical Trial
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | March 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI | Nairobi |
Lead Sponsor | Collaborator |
---|---|
University of York | European and Developing Countries Clinical Trials Partnership (EDCTP), European Vaccine Initiative, Kenya Medical Research Institute, Makerere University, University of Gondar, University of Khartoum |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 36 months | |
Primary | Parasite load in skin | Identification of parasite load in skin biopsies from patients with VL | 36 months | |
Secondary | Parasite genotype | Evaluate parasite genotype in relation to immune response characteristics | 36 months | |
Secondary | Immunological and parasitological data across sites | To compare immunological and parasitological data across and between sites and determine possible correlates of progression to PKDL. | 36 months |
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