NCT02839811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

3.1 years

First QC Date

July 18, 2016

Last Update Submit

December 20, 2021

Conditions

Drug Hypersensitivity

Keywords

BetalactamsIn vitro diagnosis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

immediate hypersensitivity to BLC

EXPERIMENTAL

immediate hypersensitivity to BLC by In vitro diagnosis

Procedure: Immediate hypersensitivity to BLC

Interventions

Immediate hypersensitivity to BLCPROCEDURE

immediate hypersensitivity to BLC by In vitro diagnosis

immediate hypersensitivity to BLC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)

You may not qualify if:

  • patients with contraindications to BLC allergy work-up
  • patient refusal to enter the study
  • vulnerable patients according to French regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 21, 2016

Study Start

June 8, 2016

Primary Completion

July 17, 2019

Study Completion

July 17, 2019

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

FR(1)