Delayed Antibiotic Therapy in General Practice

NCT05361239 | Completed

• 2 other identifiers: CNGE-2021/032022-A00377-36
• Study Type: observational
• Target: 865
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AOM - Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Minors and adults consulting a GP for AOM

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• CNGE Conseil: lead

Study Sites (1)

MSPU Jacques Prévert10 place George Sand

Montigny-le-Bretonneux, 78180, France

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: October 20, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

FR (1)