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

NCT06596096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-07-09

No results posted yet for this study

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

Sponsors & Collaborators

  • Centre Hospitalier de Saint-Brieuc

    lead OTHER

Principal Investigators

  • Pierre FILLATRE · CENTRE HOSPITALIER SAINT-BRIEUC PAIMPOL TREGUIER REANIMATION

  • Nicolas NESSELER · CHU RENNES REANIMATION CHIRURGIE THORACIQUE CARDIAQUE ET VASCULAIRE

  • Yoann LAUNEY · CHU RENNES REANIMATION CHIRURGICALE

  • Flora DELAMAIRE · CHU RENNES REANIMATION MEDICALE

  • Guillaume RIEUL · CH BRETAGNE ATLANTIQUE REANIMATION

  • Pierre BOUJU · ch bretagne sud atlantique REANIMATION

  • Aurélien FREROU · CH ST MALO REANIMATION

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2025-06-11
Completion
2025-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596096 on ClinicalTrials.gov