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

NCT05426577 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-06-22

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis

Interventions

DIAGNOSTIC_TEST

ELISA, LAMP, Cytokine Release Assay

IgG1 ELISA: ELISA that employs soluble Leishmania lysate or protein antigen.Results are recorded as antibody titres, which are measured by the absorbance values of products generated using enzyme conjugated anti-human antibodies. Cytokine release assay (CRA): In this assay whole blood is stimulated for 24 hours with leishmania antigen. Cytokine levels are then assessed in the plasma fraction using flow cytometry with the BD™ Cytometric Bead Array for Human Cytokines or standard ELISA kits for human cytokines commercialized by Sigma-Aldrich (RAB0268-IL-2, RAB0222-IFN-g, RAB0224-IL-10, RAB0476-TNF-a, RAB0119-IP-10). LAMP test for VL: We will use the LoopampTM Leishmania Detection Kit, CE-marked and produced Eiken Chemical Co., Japan.

Sponsors & Collaborators

  • Leishmaniasis Research and Treatment Cener University of Gondar, Ethiopia

    collaborator UNKNOWN

  • WHO Collaborating Centre for Leishmaniasis, INstituto de Salud Carlos III, Spain

    collaborator UNKNOWN

  • University of Amsterdam Medical Center, Netherlands

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426577 on ClinicalTrials.gov