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

NCT06596096 | Completed

• 1 other identifier: CHSB-2022-08-P5-BETALACTACRIT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis

Keywords

Beta-lactam; Underexposure; Risk factors; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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).

  25 months

Secondary Outcomes (1)

• Count the number of participants with poor clinical outcome and pharmacological failure (< 4 times the bacterial MIC).

  25 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized in intensive care with sepsis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Saint-Brieuc: lead

Study Sites (1)

FILLATRE

Saint-Brieuc, 22000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological workup: hematological workup (CBC, platelets), blood urea, blood creatinine, urine urea, urine creatinine, blood gas, liver workup. * Plasma betalactamine determination (residual or steady-state). * Identification of bacteria responsible for infection inhibitory concentration value.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre FILLATRE

  CENTRE HOSPITALIER SAINT-BRIEUC PAIMPOL TREGUIER REANIMATION

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Aurélien FREROU

  CH ST MALO REANIMATION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 19, 2024
• Study Start: June 12, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

FR (1)