A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leis… (NCT04342715) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Kenya216 participantsStarted 2022-05-22
Plain-language 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.
Who can participate
Age range12 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Immune cell phenotypes present in peripheral blood and tissue