About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients admitted in intensive care unit for an acute brain injury caused by a traumatic brain injury or a vascular cerebral disease (ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage) with a Glasgow coma scale \< 12 and needed a mechanical ventilation for 48 hours or more, started in the first 12 hours.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of patients with PK/PD target attainment
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.
Secondary outcomes
Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae
Association between augmented renal clearance and PK/PD target attainment
Association between hyperbilirubinemia and PK/PD target attainment
Association between PK/PD target attainment and day 28 mortality
Sponsors and contacts
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