Drug Hypersensitivity
Conditions
Keywords
Betalactams, In vitro 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.
Interventions
PROCEDUREImmediate hypersensitivity to BLC
immediate hypersensitivity to BLC by In vitro diagnosis
Sponsors
European Commission
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC | up to 1 hour |
| Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC | up to 1 hour |
Countries
France
Outcome results
None listed