Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

NCT05350995 | Unknown

• 1 other identifier: U2TI-001
• Study Type: observational
• Target: 9,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease; Emergencies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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.

  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

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henri Mondor University Hospital: lead

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Emergencies

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clément Ourghanlian, PharmD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément Ourghanlian, PharmD

CONTACT

0145178029; clement.ourghanlian@aphp.fr

Raphael Lepeule, MD

CONTACT

0145178003; raphael.lepeule@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 28, 2022
• Study Start: May 13, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)