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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Critically ill patients with acute brain injury

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae

Time frame
Day 7
2

Association between augmented renal clearance and PK/PD target attainment

Time frame
24 hours
3

Association between hyperbilirubinemia and PK/PD target attainment

Time frame
24 hours
4

Association between PK/PD target attainment and day 28 mortality

Time frame
Day 28

Other outcomes

Sponsors and contacts

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