Status:
UNKNOWN
Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Kenya Medical Research Institute
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
1+ years
Brief Summary
Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; includ...
Eligibility Criteria
Inclusion
- All patients ≥ 1 year, with clinical signs and symptoms compatible with VL (fever \> 2 weeks, splenomegaly, wasting, malaria negative)
- Participants for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for participants under 18 years of age. In the case of minors 12 - 17 years, assent from the children will to be obtained in addition to parental consent.
Exclusion
- Relapse cases of VL (recrudescent infection 6-12 month after treatment).
- Participants with post-kala-azar dermal leishmaniasis
- Participants from whom, for any reason, the blood sample needed for the evaluation cannot be taken
Key Trial Info
Start Date :
December 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT05386875
Start Date
December 31 2022
End Date
June 30 2024
Last Update
April 7 2023
Active Locations (4)
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1
Turkana County
Lodwar, Kenya
2
Marsabit County
Marsabit, Kenya
3
Kenya Medical Research Institute
Nairobi, Kenya
4
Wajir County
Wajir, Kenya