NCT02839811

Medical Device for Drug Allergy Diagnosis

Compact Biophotonic Platform for Drug Allergy Diagnosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Hypersensitivity

Interventions

Type	Name	Description
PROCEDURE	Immediate hypersensitivity to BLC	immediate hypersensitivity to BLC by In vitro diagnosis

Timeline

• Start date: 2016-06-08
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2016-07-21
• Last updated: 2021-12-21

Locations

1 site across 1 country: France