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Health and Road Safety: Influence of Drugs Use and Health Status

CESIR-U2 : Influence of Drugs Use and Health Status

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02688504
Acronym
CESIR-U2
Enrollment
1200
Registered
2016-02-23
Start date
2016-10-18
Completion date
2018-12-26
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Car Accident

Keywords

labelled medicines, drivers involved in serious and non-serious road accidents, relevance and effectiveness of pictograms on medicines packaging

Brief 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 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.

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Minors * Passenger * Pedestrian * Discharge or transfer to another hospital/clinic before the interview

Design outcomes

Primary

MeasureTime frameDescription
Drugs use reported by drivers involved in road accidentsinclusion dateDrugs 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.

Secondary

MeasureTime frameDescription
Responsibility of the driver for the accidentinclusion dateThe 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)
Seriousness of the accidentinclusion dateThe 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.
Knowledge of drivers about graded pictogram featured on drugs packaginginclusion dateKnowledge 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026