NCT04001335

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	Dental Broach	Dental broach, RDT and PCR

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-06-28
• Last updated: 2021-03-04

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study