Medical Device for Drug Allergy Diagnosis | NCT02839811

Studies
Medical Device for Drug Allergy Diagnosis

NCT02839811

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

145Actual

Phase

Not Applicable

Conditions

Drug Hypersensitivity

Interventions

Immediate hypersensitivity to BLC

Countries

France

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2016Actual

Primary Completion Date

Jul 17, 2019Actual

Completion Date

Jul 17, 2019Actual

First Submitted Date

Jul 18, 2016

First Submission Date that Met QC Criteria

Jul 18, 2016

First Posted Date

Jul 21, 2016Estimated

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

Dec 20, 2021

Last Update Posted Date

Dec 21, 2021Actual

Name	Class
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device.

A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
immediate hypersensitivity to BLC	Experimental	immediate hypersensitivity to BLC by In vitro diagnosis	Procedure: Immediate hypersensitivity to BLC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immediate hypersensitivity to BLC	Procedure	immediate hypersensitivity to BLC by In vitro diagnosis	immediate hypersensitivity to BLC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC		up to 1 hour
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC		up to 1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)

Exclusion Criteria:

patients with contraindications to BLC allergy work-up
patient refusal to enter the study
vulnerable patients according to French regulation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Montpellier		Montpellier			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004342	Drug Hypersensitivity

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided