Drug HypersensitivityCOBIOPHADNCT02839811
Medical Device for Drug Allergy Diagnosis
A study testing Immediate hypersensitivity to BLC in people with Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Immediate hypersensitivity to BLC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2016to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)
Who cannot join
- patients with contraindications to BLC allergy work-up
- patient refusal to enter the study
- vulnerable patients according to French regulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compact Biophotonic Platform 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.
- Conditions
- Drug Hypersensitivity
- Being tested
- Immediate hypersensitivity to BLC
- Keywords
- Betalactams, In vitro diagnosis
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate hypersensitivity to BLCProcedure or surgery
immediate hypersensitivity to BLC by In vitro diagnosis
| Study group | Role | What they receive |
|---|---|---|
| immediate hypersensitivity to BLC | Experimental | immediate hypersensitivity to BLC by In vitro diagnosis Receives: Procedure: Immediate hypersensitivity to BLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Measured: up to 1 hour
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start8 Jun 2016
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839811
- Sponsor's protocol ID
- 9617
- Acronym
- COBIOPHAD
- Status last verified
- Dec 2021
- First submitted
- 18 Jul 2016
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compact Biophotonic Platform for Drug Allergy Diagnosis
- ClinicalTrials.gov ID
- NCT02839811
- Acronym / sponsor ID
- COBIOPHAD / 9617
- Conditions
- Drug Hypersensitivity
- Keywords
- Betalactams, In vitro diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate hypersensitivity to BLC | Experimental | Procedure: Immediate hypersensitivity to BLCimmediate hypersensitivity to BLC by In vitro diagnosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)
Key exclusion criteria (3 listed)
- patients with contraindications to BLC allergy work-up
- patient refusal to enter the study
- vulnerable patients according to French regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate hypersensitivity to BLCimmediate hypersensitivity to BLC by In vitro diagnosis | Procedure or surgery | immediate hypersensitivity to BLC |
Primary outcome
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Time frame: up to 1 hour
Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
Time frame: up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate hypersensitivity to BLC in people with Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC (time frame: up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.