CompletedNot Applicable

Delayed Antibiotic Therapy in General Practice

France865 participantsStarted 2022-10-20

Plain-language 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 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.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age greater than 6 months * At least one of the following signs: * moderate to severe tympanic membrane bulge or recent onset of otorrhea not caused by otitis externa, * mild tympanic membrane bulge associated with either: * recent onset (less than 48 hours) of otalgia (or holding, pulling, rubbing the ear in a child who does not speak) or, * tympanic erythema * Enrolled in a social security plan or beneficiary of such a plan. * Patient who has given oral non-objection after being fully informed about the protocol. Exclusion Criteria: * \- AOM in the previous 3 months or recurrent AOM (≥ 3 in 6 months or ≥ 4 in 12 months) * Presence of paracentesis tubes or perforated tympanic membrane * Acute complication of otitis (mastoiditis, meningitis, intracranial abscess, sinusal thrombosis or facial nerve paralysis) * Additional intercurrent bacterial infection such as diagnosed or suspected pneumonia * Symptomatology that suggests a more serious condition to the clinician * Hospitalization or emergency care required * Patients at risks of complication (immunosuppression) * Associated severe acute pathology * Cranio-facial malformation, down syndrom, cystic fibrosis * Antibiotic therapy in the previous seven days * Minor patient not accompanied by a legal representative (father or mother) * Patients already included in the study * Patients who does not speak french * Person subject to a legal protection measure * Persons deprived of liberty * Pr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To study associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (immediate or delayed, when antibiotic was prescribed).

Timeframe: At 14 days after inclusion

Trial details

NCT IDNCT05361239

SponsorCNGE Conseil

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-02

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