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

March 2, 2021 updated by: Institute of Tropical Medicine, Belgium

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • Institute of Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with suspicion of CL will be screened for inclusion.

Description

Inclusion Criteria:

  • Skin biopsy for leishmania test requested by treating ITM clinician OR
  • externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample
  • willing and able to provide consent/assent
  • not on CL treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CL suspicion
Patients with skin lesions suspected to be cutaneous leishmaniasis
Diagnostic test: Dental Broach
Dental broach, RDT and PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of CL detect RDT
Time Frame: 2019-2010
Against combined reference of microscopy and PCR using skin punch biopsy
2019-2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of PCR positives on dental broach sample
Time Frame: 2019-2020
Compared to PCR positives on skin punch biopsy
2019-2020
Proportion of successful species typing on dental broach sample
Time Frame: 2019-2020
Compared to successful species typing on skin punch biopsy sample
2019-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Investigators

  • Principal Investigator: Saskia van Henten, MD, Institute of Tropical Medicine
  • Study Director: Johan van Griensven, MD,PhD, Institute of Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1298/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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