Status:
TERMINATED
Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Kenya Medical Research Institute
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
4-99 years
Brief Summary
Visceral leishmaniasis (VL) or kala azar is a neglected tropical disease(NTD) caused by protozoan parasites of the Leishmania donovani complex that are transmitted by phlebotomine sand flies. An estim...
Eligibility Criteria
Inclusion
- Participants are eligible to be included in the study only if ALL of the following criteria are met:
- Patient with a confirmed diagnosis of VL based on the VL diagnostic algorithm as in the national guidelines, either before treatment or after treatment completion OR healthy individuals with no clinical signs compatible with VL.
- Participant ≥ 4 years old.
- Participant from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. In the case of minors, assent from the children (13-17 years old) will be obtained.
- Clinical samples required for the study (peripheral blood and urine) can be obtained.
Exclusion
- Participants cannot be included in the study if ANY of the following criteria apply:
- Patients \< 4 years old.
- Patients from which, for any reason, none of the sample needed (urine or blood) can be taken.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06118749
Start Date
December 20 2023
End Date
July 31 2024
Last Update
January 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
KEMRI
Nairobi, Kenya