Clinical Trial: Medical Device for Drug Allergy Diagnosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Compact Biophotonic Platform for Drug Allergy Diagnosis
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 Summary:
Sponsor: University Hospital, Montpellier
Current Primary Outcome:
- Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC [ Time Frame: up to 1 hour ]
- Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC [ Time Frame: up to 1 hour ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University Hospital, Montpellier
Dates:
Date Received: July 18, 2016
Date Started: May 2016
Date Completion: May 2017
Last Updated: July 18, 2016
Last Verified: July 2016
