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

Cutaneous Leishmaniases Clinical Trial

— RapidLeish  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04001335
• Other study ID #: 1298/19
• Status: Terminated
• Start date: August 12, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniases
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Diagnostic Test:
• Dental Broach
Dental broach, RDT and PCR

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CL detect RDT	Against combined reference of microscopy and PCR using skin punch biopsy	2019-2010
Secondary	Proportion of PCR positives on dental broach sample	Compared to PCR positives on skin punch biopsy	2019-2020
Secondary	Proportion of successful species typing on dental broach sample	Compared to successful species typing on skin punch biopsy sample	2019-2020