PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Early Ventilator Associated Pneumonia, Acute Brain Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Percentage of patients with PK/PD target attainment [Time frame: 24 hours]
Secondary outcome measures (6)
- Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae [Time frame: Day 7]
- Association between augmented renal clearance and PK/PD target attainment [Time frame: 24 hours]
- Association between hyperbilirubinemia and PK/PD target attainment [Time frame: 24 hours]
- Association between PK/PD target attainment and day 28 mortality [Time frame: Day 28]
- Association between PK/PD target attainment and ICU length of stay [Time frame: 3 months]
- Incidence of multi drug resistance bacteria [Time frame: Day 28]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- CHRU de Nancy - Hôpital Central — Nancy
- CHRU Nancy - Hopital Central — Nancy
Identifiers
NCT: NCT07450404 · 2025PI164