EVAPAUR: Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

Sponsor
Henri Mondor University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05350995
Collaborator
(none)
9,600
1
10.6
904.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
9600 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Adequacy to local or national recommendations of antibiotic prescriptions identified on patient discharge prescriptions after a visit in emergency departments. [through study completion, an average of 1 year]

    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).

Secondary Outcome Measures

  1. Adequacy to the local or national recommendations of the antibiotic prescriptions identified on the patient discharge prescriptions by diagnosis. [Through study completion, an average of 1 year]

    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).

  2. Antibiotics prescription rate at discharge from emergency department. [Through study completion, an average of 1 year]

  3. Critical antibiotics prescription rate at discharge from emergency department. [Through study completion, an average of 1 year]

    Critical antibiotics are defined by ANSM guidelines.

  4. Factors associated with inadequacy to the local or national recommendations. [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Henri Mondor Créteil France 94000

Sponsors and Collaborators

  • Henri Mondor University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clement OURGHANLIAN, Principal Investigator, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT05350995
Other Study ID Numbers:
  • U2TI-001
First Posted:
Apr 28, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022