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ADOMA
Sponsor study identifier
Secondary identifiers
OTHER · IDRCB
observational
865
1 country
1
Study Start
October 20, 2022
Actual (reported)Primary Completion
May 2, 2024
Actual (reported)Study Completion
May 2, 2024
Actual (reported)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 More 330 general practitioners in France will recruit 2800 patients older than 6 months with acute otitis media between September 2022 and April 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2022
Actual (reported)May 4, 2022
Actual (reported)October 20, 2022
Actual (reported)May 2, 2024
Actual (reported)May 2, 2024
Actual (reported)To study associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (immediate or delayed, when antibiotic was prescribed).
Identification of associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (intial or delayed) when antibiotic was prescribed
At 14 days after inclusion
Study the factors associated with no antibiotic prescription
At 14 days after inclusion
Describe the frequency of each strategy in our study sample
At 14 days after inclusion
Describe the frequency of antibiotic use by patients according to choice of antibiotic strategy.
At 14 days after inclusion
Describe factors associated with antibiotic consumption
At 14 days after inclusion
Determine a typical profile of patients using antibiotics outside of their GP's recommendations in case of delayed antibiotic prescription
At 14 days after inclusion
Minors and adults consulting a GP for AOM
MSPU Jacques Prévert10 place George Sand
Montigny-le-Bretonneux, 78180, France
865 participants (actual enrollment reported by the registry).
First Submitted
April 29, 2022
First Posted
May 4, 2022
Study Start
October 20, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 2, 2024
Actual (reported)Study Completion
May 2, 2024
Actual (reported)Last Updated
July 3, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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