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

Institute of Tropical Medicine, Belgium

Status: Terminated

Conditions: Cutaneous Leishmaniases

Treatments: Diagnostic Test: Dental Broach

Study type: Observational

Funder types: Other

Identifiers

NCT04001335

1298/19

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

6 participants in 1 patient group

CL suspicion

Description:

Patients with skin lesions suspected to be cutaneous leishmaniasis

Treatment:

Diagnostic Test: Dental Broach