Evaluation of the Impact of the Modification of Antibiotic Susceptibility Testing on Antibiotic Prescriptions

NCT05902299 | Unknown

• 1 other identifier: 2022PI193
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antibiotic Resistant Infection

Keywords

Antibiotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparison of prescription rates for antibiotics concerned

  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)

Study Arms (2)

Before antibiotic susceptibility testing

Drug: Antibiotic

After antibiotic susceptibility testing

Interventions

Antibiotic DRUG

Evaluate the choice of antibiotic therapy prescribed for P. aeruginosa ou S. aureus infection

Before antibiotic susceptibility testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Alexandre CHARMILLON, Dr

CONTACT

0383155536; A.CHARMILLON@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., department of infectious and tropical diseases

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 13, 2023
• Study Start: May 15, 2023
• Primary Completion: May 16, 2023
• Study Completion: July 3, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)