Status:
COMPLETED
Delayed Antibiotic Therapy in General Practice
Lead Sponsor:
CNGE Conseil
Conditions:
AOM - Acute Otitis Media
Eligibility:
All Genders
6+ years
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...
Detailed 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 cha...
Eligibility Criteria
Inclusion
- 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
- \- 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
- Pregnant women, parturients and breastfeeding mothers
Key Trial Info
Start Date :
October 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2024
Estimated Enrollment :
865 Patients enrolled
Trial Details
Trial ID
NCT05361239
Start Date
October 20 2022
End Date
May 2 2024
Last Update
July 3 2024
Active Locations (1)
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1
MSPU Jacques Prévert10 place George Sand
Montigny-le-Bretonneux, France, 78180