Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure (VL-ToC)

NCT05426577 UNKNOWN

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.

Details

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Status	UNKNOWN
Enrolment	60
Start date	2021-09-01
Completion	2022-12

Conditions

• Visceral Leishmaniasis

Interventions

• ELISA, LAMP, Cytokine Release Assay

Primary outcomes

• To assess the diagnostic performance of the immunological tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment — At 6 month follow up
  Sensitivity, specificity, positive and negative predictive values will be reported
• To assess the diagnostic performance of the molecular tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment — At 6 month follow up
  Sensitivity, specificity, positive and negative predictive values will be reported

Countries

Ethiopia