Back to resultsMedical Device for Drug Allergy Diagnosis (COBIOPHAD)
Primary Purpose
Drug Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate hypersensitivity to BLC
Sponsored by
About this trial
This is an interventional diagnostic trial for Drug Hypersensitivity focused on measuring Betalactams, In vitro diagnosis
Eligibility Criteria
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
Sites / Locations
- University hospital of Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
immediate hypersensitivity to BLC
Arm Description
immediate hypersensitivity to BLC by In vitro diagnosis
Outcomes
Primary Outcome Measures
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Secondary Outcome Measures
Full Information
NCT ID
NCT02839811
First Posted
July 18, 2016
Last Updated
December 20, 2021
Sponsor
University Hospital, Montpellier
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT02839811
Brief Title
Medical Device for Drug Allergy Diagnosis
Acronym
COBIOPHAD
Official Title
Compact Biophotonic Platform for Drug Allergy Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2016 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Hypersensitivity
Keywords
Betalactams, In vitro diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate hypersensitivity to BLC
Arm Type
Experimental
Arm Description
immediate hypersensitivity to BLC by In vitro diagnosis
Intervention Type
Procedure
Intervention Name(s)
Immediate hypersensitivity to BLC
Intervention Description
immediate hypersensitivity to BLC by In vitro diagnosis
Primary Outcome Measure Information:
Title
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Time Frame
up to 1 hour
Title
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Time Frame
up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Medical Device for Drug Allergy Diagnosis
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