AOM - Acute Otitis MediaADOMANCT05361239
Delayed Antibiotic Therapy in General Practice
An observational study of AOM - Acute Otitis Media, run by CNGE Conseil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- AOM - Acute Otitis Media
- How many people
- 865 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2022to 2 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Minors and adults consulting a GP for AOM
Who may be able to join
- 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.
Who cannot join
- - 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
MSPU Jacques Prévert10 place George Sand
Montigny-le-Bretonneux, 78180
About this study
Official title: Delayed Antibiotic Therapy in General Practice : Example of Acute Otitis Media in Adults and Children Over 6 Months of Age
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.
Read more
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.
Read the 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 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.
- Conditions
- AOM - Acute Otitis Media
- Medical subject headings
- Otitis Media
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 14 days after inclusion
Secondary outcomes (5)
Study the factors associated with no antibiotic prescription
Identification of associated factors with no antibiotic prescription
Measured: At 14 days after inclusion
Describe the frequency of each strategy in our study sample
Frequencies of each antibiotic strategy used by GPs (initial antibiotic, delayed antibiotic, no antibiotic) in our sample of GPs
Measured: At 14 days after inclusion
Describe the frequency of antibiotic use by patients according to choice of antibiotic strategy.
Frequencies of antibiotic consumption by patients according to the choice of antibiotic strategy (immediate, delayed or absent)
Measured: At 14 days after inclusion
Describe factors associated with antibiotic consumption
Frequencies of antibiotic consumption by patients.
In case of delayed antibiotic prescription, frequencies of antibiotic consumption by patients :
- According to GP's recommandation
- In spite of GP's recommandation
Measured: 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
Identification of the different patient factors associated with antibiotic consumption, and more specifically with the use of antibiotics in spite of GP's recommendations, in order to define a typical profile
Measured: At 14 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start20 Oct 2022
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AOM - Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNGE Conseil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361239
- Sponsor's protocol ID
- CNGE-2021/03
- Other IDs
- 2022-A00377-36
- Acronym
- ADOMA
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Antibiotic Therapy in General Practice : Example of Acute Otitis Media in Adults and Children Over 6 Months of Age
- ClinicalTrials.gov ID
- NCT05361239
- Acronym / sponsor ID
- ADOMA / CNGE-2021/03
- Conditions
- AOM - Acute Otitis Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- CNGE ConseilUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Minors and adults consulting a GP for AOM
Key inclusion criteria (8 listed)
- Age greater than 6 months
- At least one of the following signs:
- 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.
Key exclusion criteria (16 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To study associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (immediate or delayed, when antibiotic was prescribed).
Time frame: At 14 days after inclusion
Identification of associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (intial or delayed) when antibiotic was prescribed
5 secondary outcomes
Study the factors associated with no antibiotic prescription
Time frame: At 14 days after inclusion
Describe the frequency of each strategy in our study sample
Time frame: At 14 days after inclusion
Describe the frequency of antibiotic use by patients according to choice of antibiotic strategy.
Time frame: At 14 days after inclusion
Describe factors associated with antibiotic consumption
Time frame: 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
Time frame: At 14 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AOM - Acute Otitis Media, run by CNGE Conseil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study associated factors (GPs, patients, severity of illness) with the choice of antibiotic strategy (immediate or delayed, when antibiotic was prescribed). (time frame: At 14 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.