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

NCT04001335 | Terminated FDA Device

• 1 other identifier: 1298/19
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniases

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CL detect RDT

  Against combined reference of microscopy and PCR using skin punch biopsy

  2019-2010

Secondary Outcomes (2)

• Proportion of PCR positives on dental broach sample

  2019-2020

• Proportion of successful species typing on dental broach sample

  2019-2020

Study Arms (1)

CL suspicion

Patients with skin lesions suspected to be cutaneous leishmaniasis

Diagnostic Test: Dental Broach

Interventions

Dental Broach DIAGNOSTIC_TEST

Dental broach, RDT and PCR

CL suspicion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspicion of CL will be screened for inclusion.

You may qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Saskia van Henten, MD

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Johan van Griensven, MD,PhD

  Institute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: August 12, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

BE (1)