NCT06113107

Brief Summary

Modification of the rendering of the antibiogram at the Strasbourg University Hospital in November 2019 with the appearance of the concept of "standard dose" or "high dose" sensitivity. This modification seems to have favored an inappropriate overprescription of Meropenem (the only antibiotic made "at standard dose") in Pseudomonas infections sensitive to other beta-lactams. In June 2021, it was therefore decided to mask sensitivity to carbapenems by default in the rendering of Pseudomonas antibiograms when the strain was sensitive to a narrower spectrum beta-lactam ("restricted" antibiogram). The aim of this study is to evaluate the impact of these changes in the antibiogram on antibiotic prescriptions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2024

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 24, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

PseudomonasMeropenemMicrobial susceptibility testingEUCAST breakpointAntibiotic stewardship

Outcome Measures

Primary Outcomes (1)

  • Proportion of Meropenem prescriptions in Pseudomonas spp bacteraemia susceptible to narrow-spectrum betalactams

    This study is retrospective, the analysis focuses on the medical records of patients treated at the Strasbourg University Hospital between June 1, 2018 and November 30, 2022.

    Files analysed retrospectively from June 1, 2018 to November 30, 2022 will be examined

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥18 years old) with a positive blood culture result for Pseudomonas spp identified in the microbiology laboratory of Strasbourg University Hospital during the period from June 1, 2018 to November 30, 2022

You may qualify if:

  • Major subject (≥18 years old)
  • Subject with a positive blood culture result for Pseudomonas spp identified in the microbiology laboratory of Strasbourg University Hospital during the period from June 1, 2018 to November 30, 2022
  • Subject not opposing the reuse of their data for the purposes of this research.

You may not qualify if:

  • Subject having expressed opposition to participating in the study,
  • Pseudomonas spp strain resistant to all first-line beta-lactams (Piperacillin-Tazobactam, Ceftazidime, Céfepime and Aztreonam).
  • Pseudomonas spp strain resistant to Meropenem.
  • Lack of information on the antibiotic treatment undertaken.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 2, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 13, 2024

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations