Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care

NCT07359287 | Recruiting

• 1 other identifier: 24-0171
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Otitis Media (AOM); Serous or Congestive Otitis; Acute Sinusitis; Viral Respiratory Infection (e.g., Influenza); Community-Acquired Pneumonia (CAP); Rhinitis / Nasopharyngitis; Angina; Acute Bronchiolitis; Acute Bronchitis; COPD Exacerbation (AECOPD); Laryngitis

Keywords

Upper respiratory tract infection; Lower respiratory tract infection

Outcome Measures

Primary Outcomes (1)

• Number of antibiotic treatment days prescribed for upper and lower respiratory tract infections.

  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)

Study Arms (2)

Control group

NO INTERVENTION

The primary care practices in the control group do not receive any intervention and continue patient management according to their usual practices.

Intervention group

EXPERIMENTAL

For the intervention group, two planned interventions will be planed and applied to the primary care practices: 1. Use of the OPIV (Viral Infection Prescription Tool). 2. A multidisciplinary collaboration protocol between general practitioners and pharmacists to evaluate antibiotic treatment durations. This intervention aims to strengthen collaborative practices. If a prescribed duration does not comply with recommendations, the pharmacist will discuss it with the prescriber, and the duration will be adjusted accordingly."

Other: Antibiotic prescribing according to guidelines

Interventions

Antibiotic prescribing according to guidelines OTHER

If necessary, the general practitioner prescribes antibiotics to patients consulting for an upper or lower respiratory tract infection, according to the guidelines.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• \- Patient under legal protection

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CAEN Normandie

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Angina Pectoris; Bronchitis; Laryngitis; Otitis Media; Influenza, Human; Community-Acquired Pneumonia; Rhinitis; Nasopharyngitis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Laryngeal Diseases; Otorhinolaryngologic Diseases; Otitis; Ear Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Community-Acquired Infections; Pneumonia; Nose Diseases; Pharyngitis; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases

Central Study Contacts

Renaud Verdon, PU-PH

CONTACT

+33231064709; verdon-r@chu-caen.fr

Pascal Thibon, PH

CONTACT

+33231065150; thibon-p@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)