UnknownNot Applicable

Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure

Ethiopia60 participantsStarted 2021-09-01

Plain-language 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 current laboratory tool to help assessing cure, treatment failure and relapse is microscopy, based on invasive sampling (e.g. splenic or bone marrow aspirate). Non-invasive, more sensitive tools will enable these assessments with minimum risk and discomfort to patients. This study aims to evaluate immunological and molecular tests to predict cure and relapse, and to replace with these the current invasive methods. The study will be conducted at the Leishmaniasis Research and Treatment Centre (LRTC), Gondar University Hospital, Ethiopia It will be a non-intervention study, the tools under evaluation will be considered as index tests; their results will not influence patient management during the duration of the study. Patient management will follow the national guidelines for VL diagnosis and management in Ethiopia.

Who can participate

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: * 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 Criteria: 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.

What they're measuring

To assess the diagnostic performance of the immunological tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

Timeframe: At 6 month follow up

To assess the diagnostic performance of the molecular tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

Timeframe: At 6 month follow up

Trial details

NCT IDNCT05426577

SponsorFoundation for Innovative New Diagnostics, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Visceral Leishmaniasis trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess the diagnostic performance of the immunological tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

Timeframe: At 6 month follow up

To assess the diagnostic performance of the molecular tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

Timeframe: At 6 month follow up