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Not yet recruitingNCT07450404NeuroPKVAPUpdated Mar 4, 2026

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

An observational study in Early Ventilator Associated Pneumonia and Acute Brain Injuries, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Early Ventilator Associated Pneumonia
  • Acute Brain Injuries

Keywords

  • Antibiotic prophylaxis
  • ventilator associated pneumonia
  • augmented renal clearance
  • PK/PD target attainment
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In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's planned enrollment of 60 is below the median of 140 across 127 observational studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

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

  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

07

Study locations

2 sites
  • CHRU de Nancy - Hôpital Central
    Nancy, Lorraine 54000, France
  • CHRU Nancy - Hopital Central
    Nancy, Meurthe-et-Moselle 54000, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07450404
Lead sponsor
Central Hospital, Nancy, France
Responsible party
STEIB Maureen (Assistante Spécialiste, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 4, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Maureen Steib, MD
Contact
m.steib@chru-nancy.fr
+33 3 83 85 10 45
Emmanuel NOVY, MD,PhD
study director · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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