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NCT Number: NCT07450404

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy - Hôpital Central, Nancy, Lorraine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients with PK/PD target attainment

    Time frame: 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 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

  5. Association between PK/PD target attainment and ICU length of stay

    Time frame: 3 months

  6. Incidence of multi drug resistance bacteria

    Time frame: Day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Maureen Steib, MD

CONTACT

[email protected]

+33 3 83 85 10 45

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: NeuroPKVAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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