Medical Device for Drug Allergy Diagnosis (COBIOPHAD)

University Hospital Center (CHU)

Status: Completed

Conditions: Drug Hypersensitivity

Treatments: Procedure: Immediate hypersensitivity to BLC

Study type: Interventional

Funder types: Other

Identifiers

NCT02839811

9617

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

immediate hypersensitivity to BLC

Experimental group

Description:

immediate hypersensitivity to BLC by In vitro diagnosis

Treatment:

Procedure: Immediate hypersensitivity to BLC