PseudomonasMero-PyoNCT06113107
Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia
An observational study of Pseudomonas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 13 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Yvon RUCH, MD, 33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr
Aurore BAERT, MD, 33 3 69 55 12 19, aurore.baert@chru-strasbourg.fr
About this study
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.
Read more
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.
- Conditions
- Pseudomonas
- Keywords
- Pseudomonas, Meropenem, Microbial susceptibility testing, EUCAST breakpoint, Antibiotic stewardship
- Medical subject headings
- Pseudomonas Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Files analysed retrospectively from June 1, 2018 to November 30, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completion13 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudomonasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113107
- Sponsor's protocol ID
- 8786
- Acronym
- Mero-Pyo
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia
- ClinicalTrials.gov ID
- NCT06113107
- Acronym / sponsor ID
- Mero-Pyo / 8786
- Conditions
- Pseudomonas
- Keywords
- Pseudomonas, Meropenem, Microbial susceptibility testing, EUCAST breakpoint, Antibiotic stewardship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 13 Mar 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Meropenem prescriptions in Pseudomonas spp bacteraemia susceptible to narrow-spectrum betalactams
Time frame: Files analysed retrospectively from June 1, 2018 to November 30, 2022 will be examined
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomonas, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvon RUCH, MD (33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Meropenem prescriptions in Pseudomonas spp bacteraemia susceptible to narrow-spectrum betalactams (time frame: Files analysed retrospectively from June 1, 2018 to November 30, 2022 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.