Last reviewed · How we verify
NCT05361239: ADOMA
Delayed Antibiotic Therapy in General Practice
trial in AOM - Acute Otitis Media in 865 participants. Completed in 2 May 2024.
2 May 2024
Quick facts
| Lead sponsor | CNGE Conseil |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 865 |
| Start date | 20 October 2022 |
| Primary completion | 2 May 2024 |
| Estimated completion | 2 May 2024 |
| Sites | 1 location across France |
Conditions studied
- AOM - Acute Otitis Media — all drugs for AOM - Acute Otitis Media →
Sponsor
CNGE Conseil
Who can join
6 Months and older, any sex, with AOM - Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05361239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other CNGE Conseil trials
Trials by the same sponsor.
- NCT06854965 — Cohort Study on Factors Associated with the Evolution of Quality of Life Among Transgender Individuals in the French Pop · not yet recruiting
- NCT06074536 — Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening · NA · recruiting
- NCT07476521 — Formalization of an Evaluation Grid for Assessing the Quality of Visual Aids to Enhance Individual Health Education in G · completed
- NCT05847036 — Profiles of Urinary Tract Infections in General Practice · recruiting
- NCT05531201 — Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05361239 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CNGE Conseil
- Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05361239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing