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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05902299
Collaborator
(none)
199
1
1.6
123.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
199 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Modification of Antibiotic Susceptibility Testing: Evaluation of the Impact of This Change on Antibiotic Prescriptions at the Nancy Regional University Hospital
Actual Study Start Date :
May 15, 2023
Actual Primary Completion Date :
May 16, 2023
Anticipated Study Completion Date :
Jul 3, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. comparison of dosage [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)]

    Dosage: number of DDDs (defined daily doses) / 1000 DH (hospitalization day). Dosage is calculated for all antibiotics, by class and then by molecule.

Secondary Outcome Measures

  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)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Vandoeuvre les nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHARMILLON Alexandre, Ph.D., department of infectious and tropical diseases, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05902299
Other Study ID Numbers:
  • 2022PI193
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
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
Keywords provided by CHARMILLON Alexandre, Ph.D., department of infectious and tropical diseases, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2023