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Clinical Trial Summary

Introduction In 2019, France was the 4th highest consumer of antibiotics in Europe. Among the interventions proposed to reduce antibiotic prescribing, delayed prescribing deserves particular attention. The effectiveness of delayed antibiotic prescription in reducing antibiotic consumption remains poorly studied in the literature, and no study has yet been conducted in France. The main objective of our study is to investigate the factors associated with the choice of antibiotic strategy(immediate or deferred). The secondary objectives are to study the frequency and factors associated with antibiotic consumption according to the initial prescription, and to determine the typical profiles of patients, in the context of a delayed prescription, who consume the antibiotic outside the GP's recommendations. Method 330 general practitioners in Ile-de-France will recruit 2800 patients older than 6 months with acute otitis media between September 2022 and March 2023. GPs will be recruited via the CNGE investigator network, the colleges of general medicine in Ile-de-France, the Sentinelles network, the French Medical Association and the regional unions of health professionals. Initial medical data will be collected by the physicians. Patients will fill in daily data for 2 weeks to monitor their disease. They will also fill in social data, and questionnaires assessing their level of health literacy, confidence and satisfaction with the general practitioner consulted. Factors associated with the physician's choice of antibiotic therapy and the patients' consumption of antibiotics will be analyzed via mixed models. Consumption rates will be expressed as percentages with their confidence intervals. Conclusion This work will allow a better understanding of the elements that guide physicians towards delayed prescription. It can help physicians to better assess patients who are likely to be non-compliant with delayed prescription in order to avoid this type of prescription for them.


Clinical Trial Description

In 2018, France was the third country in Europe for antibiotic consumption. Each year, 33,000 deaths in Europe, from which 12,500 in France, could be due to antibiotic-resistant bacteria . Without changes in practice, antibiotic-resistant bacteria could be responsible for more than 10 million deaths worldwide by 2050. In France, Général Practitioners (GP) are responsible for most antibiotic prescriptions and 2nd prescribers in Europe. The annual cost of antibiotic overconsumption, in primary care, is estimated between 71 and 442 millions euros. Otolaryngology's infections are responsible for 44% of these prescriptions. While antibiotic consumption has been declining since 2000, the situation seems to be reversing since 2010 with an increase of 5.6% between 2011 and 2016. Several interventions on GP's have been evaluated to reduce antibiotic use, but none seemed to prove a mid/long term efficacy. Patient interventions combined with physician interventions appear to be more effective. Delayed antibiotic prescribing (DAP), a method of delaying the filling of an antibiotic prescription for at least 48 hours, deserves special attention. The effectiveness of DAP in reducing antibiotic consumption remains poorly studied in the literature, and no study has yet been conducted in France. Physicians consider acute otitis media to be the most appropriate condition for PDA, mainly because of doubts about the value of antibiotics in this condition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05361239
Study type Observational
Source CNGE Conseil
Contact Mathilde FRANCOIS, Dr
Phone 06.61.41.96.16
Email dr.francois.m@gmail.com
Status Recruiting
Phase
Start date October 20, 2022
Completion date March 2024

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