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Trial record 2 of 64 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Medical Device for Drug Allergy Diagnosis (COBIOPHAD)

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ClinicalTrials.gov Identifier: NCT02839811
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Drug Hypersensitivity Procedure: Immediate hypersensitivity to BLC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Compact Biophotonic Platform for Drug Allergy Diagnosis
Actual Study Start Date : June 8, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: immediate hypersensitivity to BLC
immediate hypersensitivity to BLC by In vitro diagnosis
Procedure: Immediate hypersensitivity to BLC
immediate hypersensitivity to BLC by In vitro diagnosis




Primary Outcome Measures :
  1. Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC [ Time Frame: up to 1 hour ]
  2. Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC [ Time Frame: up to 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839811


Contacts
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Contact: Anca CHIRIAC, MD a-chiriac@chu-montpellier.fr

Locations
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France
University hospital of Montpellier Recruiting
Montpellier, France
Contact: Anca CHRIAC, MD       a-chiriac@chu-montpellier.fr   
Principal Investigator: anca chiriac, MD         
Sponsors and Collaborators
University Hospital, Montpellier
European Commission

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02839811     History of Changes
Other Study ID Numbers: 9617
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
Betalactams
In vitro diagnosis
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders