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NCT02839811 Clinical Trial

Medical Device for Drug Allergy Diagnosis

Drug Hypersensitivity Clinical Trial

— COBIOPHAD  

Official title:
Compact Biophotonic Platform for Drug Allergy Diagnosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02839811
Other study ID # 9617
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2016
Est. completion date July 17, 2019

Study information
Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date July 17, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Immediate hypersensitivity to BLC
immediate hypersensitivity to BLC by In vitro diagnosis

Locations
Country Name City State
France University hospital of Montpellier Montpellier

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Montpellier European Commission

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC up to 1 hour
Primary Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC up to 1 hour
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