Medical Device for Drug Allergy Diagnosis
- Conditions
- Drug Hypersensitivity
- Interventions
- Procedure: Immediate hypersensitivity to BLC
- Registration Number
- NCT02839811
- Lead Sponsor
- University Hospital, Montpellier
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)
- patients with contraindications to BLC allergy work-up
- patient refusal to enter the study
- vulnerable patients according to French regulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description immediate hypersensitivity to BLC Immediate hypersensitivity to BLC immediate hypersensitivity to BLC by In vitro diagnosis
- Primary Outcome Measures
Name Time Method Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC up to 1 hour Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC up to 1 hour
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University hospital of Montpellier
🇫🇷Montpellier, France