Status:
UNKNOWN
Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Leishmaniasis Research and Treatment Cener University of Gondar, Ethiopia
WHO Collaborating Centre for Leishmaniasis, INstituto de Salud Carlos III, Spain
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
Brief Summary
Left untreated, visceral leishmaniasis (VL) is fatal. The highest burden of VL worldwide is in eastern Africa where field-adapted diagnostic and test-of-cure tools and treatment are lacking. The curre...
Detailed Description
CONTEXT Visceral leishmaniasis (VL), or kala-azar, is caused by parasitic protozoa of the Leishmania donovani species complex, which are transmitted by the bite of infected female phlebotomine sand fl...
Eligibility Criteria
Inclusion
- Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis.
- Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age (in the case of minors, assent from the children also needs to be obtained as per country regulatory requirements).
Exclusion
- VL cases will not be enrolled in the study if any of the following exclusion criteria apply:
- Patients who are cases of VL relapse, post- or para-kala-azar dermal leishmaniasis or who have received any anti-leishmanial drugs within the last six months.
- Patients not eligible for treatment with SSG+PM:
- Patients with severe malnutrition.
- Patients with positive HIV diagnosis.
- Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments (SSG or PM).
- Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG.
- Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic), or chronic condition which would preclude evaluation of the patient's response to study medication.
- Patients who cannot comply with the planned procedures and scheduled visits of the study protocol.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05426577
Start Date
September 1 2021
End Date
December 1 2022
Last Update
June 22 2022
Active Locations (1)
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1
Leishmaniasis Research and Treatment Centre, Gondar University Hospital
Gonder, Ethiopia, PO BOX 196