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Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium

NCT04001335 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2021-03-04

No results posted yet for this study

Summary

Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.

At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.

The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.

How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.

Conditions

  • Cutaneous Leishmaniases

Interventions

DIAGNOSTIC_TEST

Dental Broach

Dental broach, RDT and PCR

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Saskia van Henten, MD · Institute of Tropical Medicine

  • Johan van Griensven, MD,PhD · Institute of Tropical Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2021-03-01
Completion
2021-03-01
FDA Device
Yes

Countries

  • Belgium

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 NCT04001335 on ClinicalTrials.gov