Evaluation of the Impact of the Modification of Antibiotic Susceptibility Testing on Antibiotic Prescriptions (IPMRA)

Modification of Antibiotic Susceptibility Testing: Evaluation of the Impact of This Change on Antibiotic Prescriptions at the Nancy Regional University Hospital

As of 2019, the CA-SFM (Comité de l'Antibiogramme de la Société Française de Microbiologie) recommends that the letter "I" or the term "intermediate" on antibiotic antibiograms. Instead, it is recommended that the term "sensible à forte posologie" or "SFP". These recommendations have been in place since 21/01/2022 at Nancy University Hospital.

Pseudomonas aeruginosa is the bacterium most affected by this change, as it has a high proportion of "high dosage" antibiotics.

Staphylococcus aureus is the most widely isolated bacterium, and also impacted by the change in antibiotic susceptibility testing.

The aim of this change in recommendations is to guarantee the efficacy of the proposed molecules.

Main objective Evaluate the impact of the change in antibiogram recommendations in samples positive for Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (prescribed dosage)

Secondary objectives

• Evaluate the impact of changing the way antibiograms in Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (molecule prescribed).
• Evaluate the impact of changing the way antibiograms on antibiotic therapy (molecule and dosage prescribed), depending on the strain identified (Pseudomonas aeruginosa or Staphylococcus aureus).
• Describe the impact of changing antibiograms in Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (molecule and dosage prescribed) by department.

Study Overview

• Status: Recruiting
• Conditions: Antibiotic Resistant Infection
• Intervention / Treatment: Drug: Antibiotic

• Study Type: Observational
• Enrollment (Estimated): 199

Contacts and Locations

• Study Contact: Name: Alexandre CHARMILLON, Dr; Phone Number: 0383155536; Email: A.CHARMILLON@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre les nancy, France, 54511
    • Recruiting
    • Chru Nancy
    • Contact: Alexandre CHARMILLON, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All adult patients hospitalized who had a positive monobacterial sample for P. aeruginosa or S.aureus resulting in an antibiotic susceptibility test between 01/03/2021 and between 01/03/2021 and 31/08/2021 and between 01/03/2022 and 31/08/2022 and having received antibiotic therapy for this infection

Description

Inclusion Criteria:

• Patients hospitalized with a positive monobacterial P. aeruginosa or S.aureus resulting in an antibiotic susceptibility test between 01/03/2021 and 31/08/2021 (AVANT period) and between 01/03/2022 and 31/08/2022 (AFTER period)

Exclusion Criteria:

• patients from the maternity unit / the Centre Chirurgical Emile Gallé (CCEG) / dialysis department (UF 1094)
• patients with sample results that did not result in a prescription of antibiotics documented and duplicate samples relating to the same pathology and the same documented treatment
• patient opposed to research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before antibiotic susceptibility testing	Drug: Antibiotic; Evaluate the choice of antibiotic therapy prescribed for P. aeruginosa ou S. aureus infection
After antibiotic susceptibility testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of dosage	Dosage: number of DDDs (defined daily doses) / 1000 DH (hospitalization day). Dosage is calculated for all antibiotics, by class and then by molecule.	Period before the introduction of the new antibiotic susceptibility test report (1 March to 31 August 2021) and after the introduction of the new antibiotic susceptibility test report (1 March to 31 August 2022)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of prescription rates for antibiotics concerned	Choice of molecule: antibiotic prescription rate of interest. The prescription rate will be calculated by class, then by molecule. Prescription rate = number of prescriptions of antibiotic X over the period / number of prescriptions of all antibiotics over the same period.	Period before the introduction of the new antibiotic susceptibility test report (1 March to 31 August 2021) and after the introduction of the new antibiotic susceptibility test report (1 March to 31 August 2022)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): May 16, 2023
• Study Completion (Estimated): July 3, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2022PI193

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