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

• Sponsor: Institute of Tropical Medicine, Belgium (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04001335
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Leishmaniases	Diagnostic Test: Dental Broach

Study Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
• Actual Study Start Date: Aug 12, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
CL suspicion Patients with skin lesions suspected to be cutaneous leishmaniasis	Diagnostic Test: Dental Broach; Dental broach, RDT and PCR

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of CL detect RDT [2019-2010]

   Against combined reference of microscopy and PCR using skin punch biopsy

Secondary Outcome Measures

1. Proportion of PCR positives on dental broach sample [2019-2020]

   Compared to PCR positives on skin punch biopsy

2. Proportion of successful species typing on dental broach sample [2019-2020]

   Compared to successful species typing on skin punch biopsy sample

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Tropical Medicine	Antwerp		Belgium	2000

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Tropical Medicine, Belgium
• ClinicalTrials.gov Identifier: NCT04001335
• Other Study ID Numbers: 1298/19
• First Posted: Jun 28, 2019
• Last Update Posted: Mar 4, 2021
• Last Verified: Mar 1, 2021

• 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
• Additional relevant MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous

Study Results

No Results Posted as of Mar 4, 2021