Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

Emergencies Clinical Trial

— EVAPAUR  

Official title:

Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350995
• Other study ID #: U2TI-001
• Status: Recruiting
• Start date: May 13, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Henri Mondor University Hospital
• Contact: Clément Ourghanlian, PharmD
• Phone: 0145178029
• Email: clement.ourghanlian[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9600
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Infectious Disease

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHU Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Antibiotics prescription rate at discharge from emergency department.		Through study completion, an average of 1 year
Secondary	Critical antibiotics prescription rate at discharge from emergency department.	Critical antibiotics are defined by ANSM guidelines.	Through study completion, an average of 1 year
Secondary	Factors associated with inadequacy to the local or national recommendations.		Through study completion, an average of 1 year