ClinicalTrials.gg
RecruitingNCT06113107Mero-PyoUpdated Nov 2, 2023

Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia

An observational study in Pseudomonas, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Pseudomonas Infections with a site in France — 6 open to participants now, 6 under way, 1 of them phase 3. Pseudomonas Infections · France.

Started
2023
the only one that year
Observational
5 of 23
4 open now
Registered
19th of 23
by date

Among the 23 studies in Pseudomonas Infections with a site in France, this one is the only one that started in 2023, is one of 5 observational ones, and was the 19th registered.

Pseudomonas Infections

136 studies on the registry are indexed under Pseudomonas Infections; 27 are open to participants now.

Browse Pseudomonas Infections studies →

Open to participants now

6 of the 23 studies in Pseudomonas Infections with a site in France are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 20 Pseudomonas Infections studies recruiting now, 11 (55%) set no upper age limit and 2 (10%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Pseudomonas Infections with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pseudomonas

Keywords

  • Pseudomonas
  • Meropenem
  • Microbial susceptibility testing
  • EUCAST breakpoint
  • Antibiotic stewardship
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Subject having expressed opposition to participating in the study,
  • Pseudomonas spp strain resistant to all beta-lactams (Piperacillin-Tazobactam, Ceftazidime, Céfepime and Aztreonam).
  • Pseudomonas spp strain resistant to Meropenem.
  • Lack of information on the antibiotic treatment undertaken.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

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.

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

07

Study locations

1 of 1 sites recruiting
  • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
    Strasbourg, 67091, France
    Recruiting
    • Yvon RUCH, MD · Contactyvon.ruch@chru-strasbourg.fr · 33 3 69 55 12 19
    • Aurore BAERT, MD · Contactaurore.baert@chru-strasbourg.fr · 33 3 69 55 12 19
    • Yvon RUCH, MD · Principal investigator
    • Aurore BAERT, MD · Principal investigator
    • Yasmine NIVOIX, Pharmacist · Sub investigator
    • Frédéric SCHRAMM, MD · Sub investigator
    • Julien GODET, Statistician · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Mar 2024, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2023
First posted
Nov 2, 2023
StartActual
Mar 1, 2023
Primary completionEst.
Mar 2024
CompletionEst.
Mar 13, 2024
Last update
Nov 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06113107
Responsible party
Sponsor
First posted
Nov 2, 2023
Start date
Mar 1, 2023
Primary completion
Mar 2024 (estimated)
Completion
Mar 13, 2024 (estimated)
Last update
Nov 2, 2023

Study contacts

Yvon RUCH, MD
Contact
yvon.ruch@chru-strasbourg.fr
33 3 69 55 12 19

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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