Diagnosis of Cutaneous Leishmaniasis Using the CL-detect... | NCT04001335

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

NCT04001335

Sponsor

Institute of Tropical Medicine, Belgium

Status

Terminated

Last Update Posted

Mar 4, 2021Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Cutaneous Leishmaniases

Interventions

Dental Broach

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patient recruitment possible during COVID-19, inavailability RDTs

Expanded Access Info

Start Date

Aug 12, 2019Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jun 26, 2019

First Posted Date

Jun 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CL suspicion		Patients with skin lesions suspected to be cutaneous leishmaniasis	Diagnostic Test: Dental Broach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental Broach	Diagnostic Test	Dental broach, RDT and PCR	CL suspicion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with suspicion of CL will be screened for inclusion.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saskia van Henten, MD	Institute of Tropical Medicine	Principal Investigator
Johan van Griensven, MD,PhD	Institute of Tropical Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Tropical Medicine		Antwerp		2000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D016773	Leishmaniasis, Cutaneous

Ancestor Terms

ID	Term
D007896	Leishmaniasis
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided