Cutaneous Leishmaniases Clinical Trial
— RapidLeishOfficial title:
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
NCT number | NCT04001335 |
Other study ID # | 1298/19 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | August 12, 2019 |
Est. completion date | March 1, 2021 |
Verified date | March 2021 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Institute of Tropical Medicine | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium |
Belgium,
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 |
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