Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT

July 8, 2025 updated by: Centre Hospitalier de Saint-Brieuc

Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients

Beta-lactams agents are time-dependent antibiotics. Their bactericidal effects are associated with the time spent above the minimal inhibitory concentration (MIC) of the bacteria. In ICU patients, many pathophysiological changes may occur, which significantly alter beta-lactam pharmacokinetics (increasing in distribution volume, hypoalbuminemia or change in glomerular filtration rate…), leading to antibiotic underexposure, which may explain some treatment failures and risk of emergence of a multi-resistant bacteria.

Many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the MIC. However, clinical evidences supporting that septic patients in ICU would benefit from such optimization remain low and contradictory, and use of surrogate MICs based on critical breakpoints instead of actual MICs are significant limitations in the description of beta-lactam exposure among ICU patients with sepsis.

In this study, the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure (< 4 time the MIC of the bacteria). The investigators also aim to identify association between failure and poor clinical outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The duration of patient participation extends from the inclusion visit (D1), to discharge from intensive care; if the participant is still in intensive care at D90, the last visit with data collection will be at D90. The maximum duration of participation in the study will therefore be 3 months.

Taking into account 3 months of set-up, 1 year of recruitment, 3 months of participant follow-up, 3 months of data processing and 3 months of interpretation, 2 years will be sufficient to carry out this project.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Brieuc, France, 22000
        • FILLATRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients hospitalized in intensive care with sepsis.

Description

Inclusion Criteria:

  • Participant over 18 years of age.
  • Hospitalized in intensive care unit.
  • Bacterial infection documented by culture.
  • Treatment with beta-lactam for less than 48 hours.
  • Person not objecting to participation in the study. If the particpant is unable to receive the information, it will be given to a relative and his or her non-opposition will be collected; the patient's non opposition will be sought and collected as soon as his or her condition permits.

Exclusion Criteria:

  • Measurement of MIC of the bacterium in question impossible.
  • Patients allergic to beta-lactam antibiotics.
  • Patients with an estimated hospital stay of less than 3 days.
  • Participants with "complex" infectious sites: central nervous system infection, osteoarticular infection, etc.
  • Patients already included in the present study on the occasion of a previous beta-lactam administration.
  • Adult patients under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identify proportion of participant with betalactam underexposure in critically ill patients with sepsis and predictive parameters.
Time Frame: 25 months
Under-exposure to beta-lactam antibiotics is defined as a plasma concentration below 4x the MIC of the identified bacterium. This concentration will be measured as residual in the case of discontinuous administration, or at equilibrium in the case of continuous administration. This criterion is assessed between 48 and 72 hours after the start of antibiotic therapy. Variables that will be assessed include age (in years), body mass index (in kg/m²), renal clearance (calculated with creatininemia, urinary creatininuria urinary volumeper day expressed in mL/min), SAPSII score (no unit), site of infection, modality of antibiotic administration (intermittent, continuous), time since first antibiotic injection (in hours), body temperature (in °C), SOFA score (no units), blood cell numeration (in cell/mL), coagulation parameters (in % of activity), protidemia (in g/L), lactates level (in mmol/L).
25 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Count the number of participants with poor clinical outcome and pharmacological failure (< 4 times the bacterial MIC).
Time Frame: 25 months
The secondary objective is to establish the association between under-exposure to betalactam antibiotics in ICU participants and their clinical outcome. Pharmacological failure, defined as < 4 times the bacterial MIC, will be correlated with poor clinical outcome, up to and including death.
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier de Saint-Brieuc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre FILLATRE, CENTRE HOSPITALIER SAINT-BRIEUC PAIMPOL TREGUIER REANIMATION
  • Study Chair: Nicolas NESSELER, CHU RENNES REANIMATION CHIRURGIE THORACIQUE CARDIAQUE ET VASCULAIRE
  • Study Chair: Yoann LAUNEY, CHU RENNES REANIMATION CHIRURGICALE
  • Study Chair: Flora DELAMAIRE, CHU RENNES REANIMATION MEDICALE
  • Study Chair: Guillaume RIEUL, CH BRETAGNE ATLANTIQUE REANIMATION
  • Study Chair: Pierre BOUJU, ch bretagne sud atlantique REANIMATION
  • Principal Investigator: Aurélien FREROU, CH ST MALO REANIMATION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHSB-2022-08-P5-BETALACTACRIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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