Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Lead Sponsor:
University of York
Collaborating Sponsors:
University of Gondar
Kenya Medical Research Institute
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
12-50 years
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 recruit...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04342715
Start Date
May 22 2022
End Date
March 31 2026
Last Update
July 24 2025
Active Locations (1)
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1
KEMRI
Nairobi, Kenya