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OpenTrials
Completed

NCT Number: NCT02839811

Medical Device for Drug Allergy Diagnosis

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.

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Key information

Conditions

Drug Hypersensitivity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Montpellier

Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate hypersensitivity to BLC

Procedure

immediate hypersensitivity to BLC by In vitro diagnosis

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • European Commission

Registry information

Official study title

Compact Biophotonic Platform for Drug Allergy Diagnosis

Acronym: COBIOPHAD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2016
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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