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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07450404

Acronym

NeuroPKVAP

Enrollment

Registered

2026-03-04

Start date

2026-03-01

Completion date

2027-10-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injuries, Early Ventilator Associated Pneumonia

Keywords

Antibiotic prophylaxis, ventilator associated pneumonia, augmented renal clearance, PK/PD target attainment

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame
Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae	Day 7
Association between augmented renal clearance and PK/PD target attainment	24 hours
Association between hyperbilirubinemia and PK/PD target attainment	24 hours
Association between PK/PD target attainment and day 28 mortality	Day 28
Association between PK/PD target attainment and ICU length of stay	3 months
Incidence of multi drug resistance bacteria	Day 28

Countries

France

Contacts

CONTACTMaureen Steib, MD

m.steib@chru-nancy.fr+33 3 83 85 10 45

STUDY_DIRECTOREmmanuel NOVY, MD,PhD

Central Hospital, Nancy, France

Outcome results