Car AccidentCESIR-U2NCT02688504
Health and Road Safety: Influence of Drugs Use and Health Status
An observational study of Car Accident, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram. When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Car Accident
- How many people
- 1,200 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Oct 2016to 26 Dec 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a multicentre observational study that will include 2 populations: drivers involved in serious road accidents (hospitalization > 24 hours) and non-serious road accidents (hospitalization < 24 hours). The drivers involved in road accidents and admitted in an emergency department will be identified during daily visits (except on week end) by Clinical Research Associates (CRA) of the different centres. As soon as possible, a structured validated interview will done by a trained CRA.
Who may be able to join
- Driver involved in a road accident and admitted in an emergency department
- Aged over 18 years
- Able to respond to a structured questionnaire
- Having agreed to participate in the study
Who cannot join
- Minors
- Passenger
- Pedestrian
- Discharge or transfer to another hospital/clinic before the interview
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: CESIR-U2 : Influence of Drugs Use and Health Status
In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.
When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.
Read more
This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.
This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.
- Conditions
- Car Accident
- Keywords
- labelled medicines, drivers involved in serious and non-serious road accidents, relevance and effectiveness of pictograms on medicines packaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| serious road accidents | Drivers involved in serious road accidents (hospitalization > 24 hours) | |
| non-serious road accidents | drivers involved in non-serious road accidents (hospitalization < 24 hours). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drugs use reported by drivers involved in road accidents
Drugs use is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who take drugs, by ATC classification, by pictogram and by drug.
Measured: inclusion date
Secondary outcomes (3)
Responsibility of the driver for the accident
The responsibility of the driver (responsible or not responsible) is a data extracted from the BAAC sheet (a sheet fulfilled by the police in case of traffic crashes)
Measured: inclusion date
Seriousness of the accident
The seriousness of the accident is assessed according the duration of hospital stay. If the duration is less than 24 hours, accidents are considered as non serious. If not, accidents are considered as serious.
Measured: inclusion date
Knowledge of drivers about graded pictogram featured on drugs packaging
Knowledge about graded pictogram is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who know if a pictogram is featured on their drugs packagings.
Measured: inclusion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start18 Oct 2016
- Primary completion26 Dec 2018
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Car AccidentStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas MOORE, Pr, Study chair, Plateforme BPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688504
- Sponsor's protocol ID
- CHUBX 2012/33
- Acronym
- CESIR-U2
- Status last verified
- May 2020
- First submitted
- 30 Dec 2015
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CESIR-U2 : Influence of Drugs Use and Health Status
- ClinicalTrials.gov ID
- NCT02688504
- Acronym / sponsor ID
- CESIR-U2 / CHUBX 2012/33
- Conditions
- Car Accident
- Keywords
- labelled medicines, drivers involved in serious and non-serious road accidents, relevance and effectiveness of pictograms on medicines packaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 23 Feb 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.
In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.
When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.
This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.
This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious road accidents | – | –Drivers involved in serious road accidents (hospitalization > 24 hours) |
| non-serious road accidents | – | –drivers involved in non-serious road accidents (hospitalization < 24 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a multicentre observational study that will include 2 populations: drivers involved in serious road accidents (hospitalization > 24 hours) and non-serious road accidents (hospitalization < 24 hours). The drivers involved in road accidents and admitted in an emergency department will be identified during daily visits (except on week end) by Clinical Research Associates (CRA) of the different centres. As soon as possible, a structured validated interview will done by a trained CRA.
Key inclusion criteria (4 listed)
- Driver involved in a road accident and admitted in an emergency department
- Aged over 18 years
- Able to respond to a structured questionnaire
- Having agreed to participate in the study
Key exclusion criteria (4 listed)
- Minors
- Passenger
- Pedestrian
- Discharge or transfer to another hospital/clinic before the interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drugs use reported by drivers involved in road accidents
Time frame: inclusion date
Drugs use is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who take drugs, by ATC classification, by pictogram and by drug.
3 secondary outcomes
Responsibility of the driver for the accident
Time frame: inclusion date
Seriousness of the accident
Time frame: inclusion date
Knowledge of drivers about graded pictogram featured on drugs packaging
Time frame: inclusion date
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 14 May 2020.
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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.
Nicholas MOORE, Pr study chair
Plateforme BPE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Car Accident, run by University Hospital, Bordeaux at 2 sites 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 4 inclusion and 4 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Drugs use reported by drivers involved in road accidents (time frame: inclusion date). 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 14 May 2020.