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Clinical Trials in France / NCT07450404
Starting soon Observational

PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients

NCT07450404 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Observational
Started
2026-03-01
Last updated
2026-03-04

Condition(s) studied

Early Ventilator Associated PneumoniaAcute Brain Injuries

Study summary

Critically ill patients admitted for acute brain injury are exposed to many heath-care associated infections such as ventilator associated pneumoniae (VAP). The PROHYVAP study, published in 2024 reported that a single dose of CEFTRIAXONE as an antibiotic prophylaxis could reduce the incidence of early VAP (VAP that occured between day 2 and day 7 of mechanical ventilation).

However, patients with acute brain injury also presented frequently augmented renal clearance (ARC), which could affect the pharmacokinetic and pharmacodynamic target attainment (PK/PD) of antibiotic prophylaxis.

This study aims to analyse the PK/PD target attainment after one dose of CEFTRIAXONE in critically ill patients with acute brain injury and to describe the effect of ARC on PK/PD target attainment during early VAP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years or older * Admitted in intensive care unit for acute brain injury, including traumatic brain injury and cerebral vascular disease * Glasgow coma scale inferior to 12 * Orotracheal intubation in first 12 hours of admission * Needed of invasive mechanical ventilation for at least 48 hours Exclusion Criteria: * Acute brain injury related to tumoral or infectious process * Antibiotic therapy administered before acute brain injury for an other pathology * Patients with a risk of multiresistance bacteria contamination (stay in a risk area in the past 3 months, antibiotic therapy with fluoroquinolone or betalctamine in the past 3 months, hospitalization in last month before admission, documented contaminationwith multiresistance bacteria, immunodepression) * Patients with hish risk of death in the first 48 hours * Patients with a beta-lactams reported allergy

Primary outcome measure(s)

  • Percentage of patients with PK/PD target attainment — 24 hours
    Proportion of patients with serum concentrations of CEFTRIAXONE above the minimal inhibitory concentration (MIC) of 4 mg/mL (in case of undocumented VAP), or \> 4 times the MIC of documented bacteria.

Trial sites (2)

FacilityCityRegionStatus
CHRU de Nancy - Hôpital Central Nancy Lorraine
CHRU Nancy - Hopital Central Nancy Meurthe-et-Moselle

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07450404 on ClinicalTrials.gov ↗ ← All trials in France