Early Ventilator Associated PneumoniaNeuroPKVAPNCT07450404
PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients
An observational study of Early Ventilator Associated Pneumonia and Acute Brain Injuries, run by Central Hospital, Nancy, France at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Ventilator Associated Pneumonia, Acute Brain Injuries
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2026to 1 Oct 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHRU de Nancy - Hôpital Central
Nancy, Lorraine, 54000
CHRU Nancy - Hopital Central
Nancy, Meurthe-et-Moselle, 54000
Maureen STEIB, +33 3 83 85 10 45, m.steib@chru-nancy.fr
Viviane MARTIN, PhD, v.martin3@chru-nancy.fr
About this study
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.
- Keywords
- Antibiotic prophylaxis, ventilator associated pneumonia, augmented renal clearance, PK/PD target attainment
- Medical subject headings
- Pneumonia, Ventilator-Associated, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (6)
Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae
Measured: Day 7
Association between augmented renal clearance and PK/PD target attainment
Measured: 24 hours
Association between hyperbilirubinemia and PK/PD target attainment
Measured: 24 hours
Association between PK/PD target attainment and day 28 mortality
Measured: Day 28
Association between PK/PD target attainment and ICU length of stay
Measured: 3 months
Incidence of multi drug resistance bacteria
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STEIB Maureen, Central Hospital, Nancy, France
- Investigators
- Emmanuel NOVY, MD,PhD, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450404
- Sponsor's protocol ID
- 2025PI164
- Acronym
- NeuroPKVAP
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided