- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359287
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care (GRASP)
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care: A Cluster-Randomized Trial
Antimicrobial resistance (AMR), considered one of the greatest global threats by the WHO, justifies the development of initiatives to promote appropriate antibiotic use-especially in primary care, where most antibiotics in France are prescribed and where misuse remains common.
We are proposing a cluster-randomized controlled trial to evaluate the effectiveness of a bimodal intervention combining: (1) improved communication about the circulation of respiratory viruses, and (2) strengthened collaborative practices between general practitioners and pharmacists through a multidisciplinary protocol aimed at verifying that prescribed treatment durations comply with guidelines.
The study will include six primary care practices (24 physicians), with three practices in each study arm.
The aim of this project is to assess whether the bimodal intervention can reduce the duration of antibiotic treatments for upper and lower respiratory tract infections. The first component (a "viral infection prescription" tool) focuses on reducing unnecessary treatment initiation, while the second (pharmacist-led review) aims to shorten excessive prescription durations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Renaud Verdon, PU-PH
- Phone Number: +33231064709
- Email: verdon-r@chu-caen.fr
Study Contact Backup
- Name: Pascal Thibon, PH
- Phone Number: +33231065150
- Email: thibon-p@chu-caen.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- CHU Caen Normandie
-
Contact:
- François FOURNEL, head of project
- Phone Number: +33231065488
- Email: fournel-f@chu-caen.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient seen in consultation for an upper or lower respiratory tract infection (Angina, Acute bronchiolitis, Acute bronchitis, COPD exacerbation (AECOPD), Laryngitis, Acute otitis media (AOM), Serous or congestive otitis, Viral respiratory infection (e.g., influenza), Community-acquired pneumonia (CAP), Rhinitis / Nasopharyngitis, Acute sinusitis)
Exclusion Criteria:
- Patient under legal protection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The primary care practices in the control group do not receive any intervention and continue patient management according to their usual practices.
|
|
|
Experimental: Intervention group
For the intervention group, two planned interventions will be planed and applied to the primary care practices:
|
If necessary, the general practitioner prescribes antibiotics to patients consulting for an upper or lower respiratory tract infection, according to the guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of antibiotic treatment days prescribed for upper and lower respiratory tract infections.
Time Frame: The primary outcome is measured at the time of prescription (i.e. at the baseline)
|
The primary outcome of the study will be the number of antibiotic treatment days prescribed for upper and lower respiratory tract infections.
This outcome is a composite measure reflecting the impact of both interventions.
Antibiotic duration will be assessed by running a query in the electronic medical record system of the participating primary care practices.
The primary outcome will be evaluated at the baseline.
|
The primary outcome is measured at the time of prescription (i.e. at the baseline)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Infections
- Orthomyxoviridae Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Pneumonia
- Nose Diseases
- Otorhinolaryngologic Diseases
- Ear Diseases
- Otitis
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Myocardial Ischemia
- Laryngeal Diseases
- Chest Pain
- Pharyngitis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Community-Acquired Infections
- Influenza, Human
- Respiratory Tract Infections
- Angina Pectoris
- Rhinitis
- Bronchitis
- Otitis Media
- Nasopharyngitis
- Laryngitis
- Community-Acquired Pneumonia
Other Study ID Numbers
- 24-0171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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