Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments (EVAPAUR)

French health insurance data indicate that approximately 15% of ambulatory antibiotic consumption is generated by hospital prescriptions. This extra-hospital consumption represents a greater volume than intra-hospital consumption. To date, hospital indicators of good antibiotic use do not include this outpatient dimension. This study will provide a snapshot of the proportion of ambulatory antibiotics generated by emergencies and analyze compliance with management recommendations.This study will serve as a basis for developing indicators of outpatient antibiotic consumption generated by hospital activity and for identifying specific intervention targets aimed at the misuse situations that have been highlighted.

This study will be carried out in the form of a repeated survey on a given day (4 days, one across each season), carried out by the local mobile antibiotic therapy team, using a standardized grid. The survey will concern all the medical records of the patients visiting any emergency department on the days of the survey.

The evaluation of antibiotic therapies prescribed in discharge orders will be carried out in accordance with local management recommendations by the site investigator (infectious disease and/or emergency medicine specialist), who will assess whether the prescription is in accordance with the recommendations or not.

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Infectious Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 9600

Contacts and Locations

• Study Contact: Name: Clément Ourghanlian, PharmD; Phone Number: +33 0145178029; Email: clement.ourghanlian@aphp.fr
• Study Contact Backup: Name: Raphael Lepeule, MD; Phone Number: +33 0145178003; Email: raphael.lepeule@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • CHU Henri Mondor
    • Contact: Clément Ourghanlian, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All major outpatients visiting an emergency department on one of the survey days.

Description

Inclusion Criteria:

• Visit on emergency department on one of the survey days
• Age ≥18

Exclusion Criteria:

• Patient opposed to the collection of his/her data
• Patient under guardianship or curatorship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy to local or national recommendations of antibiotic prescriptions identified on patient discharge prescriptions after a visit in emergency departments.	Adequacy to local or national recommendations (adequate/not adequate) of prescriptions, assessed by local investigator (infectious disease and/or emergency medicine specialist) at 4 days of collection: 1 day in each season (spring, summer, autumn and winter).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy to the local or national recommendations of the antibiotic prescriptions identified on the patient discharge prescriptions by diagnosis.	Adequacy to local or national recommendations (adequate/not adequate) of the antibiotic prescriptions identified on the patient discharge prescriptions by diagnosis assessed at 4 days of collection: 1 day in each season (spring, summer, autumn and winter).	Through study completion, an average of 1 year
Antibiotics prescription rate at discharge from emergency department.		Through study completion, an average of 1 year
Critical antibiotics prescription rate at discharge from emergency department.	Critical antibiotics are defined by ANSM guidelines.	Through study completion, an average of 1 year
Factors associated with inadequacy to the local or national recommendations.		Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital
• Investigators: Principal Investigator: Clément Ourghanlian, PharmD, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Infections; Communicable Diseases
• Other Study ID Numbers: U2TI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No