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

Antibiotic Resistant Infection Clinical Trial

— IPMRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902299
• Other study ID #: 2022PI193
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: July 3, 2023

Study information

• Verified date: June 2023
• Source: Central Hospital, Nancy, France
• Contact: Alexandre CHARMILLON, Dr
• Phone: 0383155536
• Email: A.CHARMILLON[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 199
• Est. completion date: July 3, 2023
• Est. primary completion date: May 16, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Disease Susceptibility

Intervention

Drug:
• Antibiotic
Evaluate the choice of antibiotic therapy prescribed for P. aeruginosa ou S. aureus infection

Locations

Country	Name	City	State
France	CHRU Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)