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

NCT07450404 | Not Yet Recruiting

• 1 other identifier: 2025PI164
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Early Ventilator Associated Pneumonia; Acute Brain Injuries

Keywords

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

Outcome Measures

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.

  24 hours

Secondary Outcomes (6)

• 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

Study Arms (1)

Critically ill patients with acute brain injury

Patients with severe acute brain injury defined by a Glasgow coma scale \< or = 8, admitted to the intensive care unit and needed invasive mechanical ventilation for at least 48 hours.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHRU de Nancy - Hôpital Central

Nancy, Lorraine, 54000, France

Location

CHRU Nancy - Hopital Central

Nancy, Meurthe-et-Moselle, 54000, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Brain Injuries

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Emmanuel NOVY, MD,PhD

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Central Study Contacts

Maureen Steib, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistante Spécialiste

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (2)