SepsisNCT06596096
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT
An observational study of Sepsis, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to 30 Jun 2025
- How long will I take part?
- 28 Days
- 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: Patients hospitalized in intensive care with sepsis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- Beta-lactam, Underexposure, Risk factors, Intensive care unit
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify proportion of participant with betalactam underexposure in critically ill patients with sepsis and predictive parameters.
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).
Measured: 25 months
Secondary outcomes (1)
Count the number of participants with poor clinical outcome and pharmacological failure (< 4 times the bacterial MIC).
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.
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Jun 2023
- Primary completion11 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Brieuc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FILLATRE, Principal investigator, CENTRE HOSPITALIER SAINT-BRIEUC PAIMPOL TREGUIER REANIMATIONNicolas NESSELER, Study chair, CHU RENNES REANIMATION CHIRURGIE THORACIQUE CARDIAQUE ET VASCULAIREYoann LAUNEY, Study chair, CHU RENNES REANIMATION CHIRURGICALEFlora DELAMAIRE, Study chair, CHU RENNES REANIMATION MEDICALEGuillaume RIEUL, Study chair, CH BRETAGNE ATLANTIQUE REANIMATIONPierre BOUJU, Study chair, ch bretagne sud atlantique REANIMATIONAurélien FREROU, Principal investigator, CH ST MALO REANIMATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596096
- Sponsor's protocol ID
- CHSB-2022-08-P5-BETALACTACRIT
- Status last verified
- Jul 2025
- First submitted
- 19 Aug 2024
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06596096
- Acronym / sponsor ID
- CHSB-2022-08-P5-BETALACTACRIT
- Conditions
- Sepsis
- Keywords
- Beta-lactam, Underexposure, Risk factors, Intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-BrieucUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care with sepsis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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
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).
1 secondary outcome
Count the number of participants with poor clinical outcome and pharmacological failure (< 4 times the bacterial MIC).
Time frame: 25 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
Pierre FILLATRE principal investigator
CENTRE HOSPITALIER SAINT-BRIEUC PAIMPOL TREGUIER REANIMATION
Nicolas NESSELER study chair
CHU RENNES REANIMATION CHIRURGIE THORACIQUE CARDIAQUE ET VASCULAIRE
Yoann LAUNEY study chair
CHU RENNES REANIMATION CHIRURGICALE
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 Sepsis, run by Centre Hospitalier de Saint-Brieuc 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify proportion of participant with betalactam underexposure in critically ill patients with sepsis and predictive parameters. (time frame: 25 months). 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 9 Jul 2025.