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

Terminated

• Conditions: Cutaneous Leishmaniases
• Interventions: Diagnostic Test: Dental Broach

• Registration Number: NCT04001335
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-08-12
• Status Verified: 2021-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CL suspicion	Dental Broach	Patients with skin lesions suspected to be cutaneous leishmaniasis

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CL detect RDT	2019-2010	Against combined reference of microscopy and PCR using skin punch biopsy

Secondary Outcome Measures

Name	Time	Method
Proportion of PCR positives on dental broach sample	2019-2020	Compared to PCR positives on skin punch biopsy
Proportion of successful species typing on dental broach sample	2019-2020	Compared to successful species typing on skin punch biopsy sample

Trial Locations

Locations (1)

Institute of Tropical Medicine; 🇧🇪 Antwerp, Belgium