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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PK/PD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients
- ClinicalTrials.gov ID
- NCT07450404
- Acronym / sponsor ID
- NeuroPKVAP / 2025PI164
- Keywords
- Antibiotic prophylaxis, ventilator associated pneumonia, augmented renal clearance, PK/PD target attainment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel NOVY, MD,PhD study director
Central Hospital, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Ventilator Associated Pneumonia and Acute Brain Injuries, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Steib, MD (+33 3 83 85 10 45, m.steib@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with PK/PD target attainment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.