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Medical Device for Drug Allergy Diagnosis

NCT ID: NCT02839811

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-08

Study Completion Date

2019-07-17

Brief Summary

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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

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Conditions

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Drug Hypersensitivity

Keywords

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Betalactams In vitro diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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immediate hypersensitivity to BLC

immediate hypersensitivity to BLC by In vitro diagnosis

Group Type EXPERIMENTAL

Immediate hypersensitivity to BLC

Intervention Type PROCEDURE

immediate hypersensitivity to BLC by In vitro diagnosis

Interventions

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Immediate hypersensitivity to BLC

immediate hypersensitivity to BLC by In vitro diagnosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9617

Identifier Type: -

Identifier Source: org_study_id