Ventilator Associated Pneumonia ( VAP)antiVAPNCT07059039
Impact of Antibio Prophylaxis on Occurence of Ventilator Associated Pneumonia in Trauma Patients
An observational study of Ventilator Associated Pneumonia ( VAP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The relevance of a short course of antibiotic prophylaxis for the prevention of ventilator assocaited pneumonia (VAP) in trauma patients, and its impact on bacterial ecology, remains to be clarified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- Type of treatment
- Injection or infusion
- How many people
- 2,143 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult trauma patients placed on mechanical ventilation during the first 24 hours of management, and for a duration of at least 48 hours
Who may be able to join
- Adult patient
- Trauma patient: admitted between 01/01/2021 and 31/12/2023 for suspected severe trauma (included in TraumaBase® )
- Put on mechanical ventilation during the first 24 hours following the start of medical care (including pre-hospital care)
- Patient on MV for at least 48 consecutive hours during intensive care stay
- Patient does not object to the use of his/her data for this research
Who cannot join
- Patient under full selective digestive decontamination protocol
- Early inhaled antibiotic prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
The relevance of a short course of antibiotic prophylaxis for the prevention of ventilator assocaited pneumonia (VAP) in trauma patients, and its impact on bacterial ecology, remains to be clarified.
Antibiotics are often administered in the pre-hospital phase, usually in cases to traumatic lesions with high risk of secondary infection (open fractures, deteriorating wounds, etc.). If there is a potential benefit of such antibiotic prophylaxis on the risk of surgical site infection, there could also be a benefit on the risk of developing pulmonary infections. Recent data have shown a reduction in the risk of early-onset VAP in cerebrovascular patients with a strategy of very early administration of antibiotic prophylaxis (PROPHYVAP study(1)), as well as in patients taken into intensive care following cardiac arrest (ANTHARTIC study(2)). The aim of the study is to evaluate the impact of early systemic antibiotic prophylaxis in trauma patients on the incidence of early VAP during the ICU stay.
Read the detailed description
VAP is the most frequent infectious complication in the Intensive Care Units (ICU), with a higher incidence in trauma patients.
Individually, the development of VAP prolongs the duration of mechanical ventilation and in-hospital lenghts of stay, and is associated with additional costs. Collectively, VAP is responsible for around half of all antibiotic consumption in the ICU, with ecological consequences through the emergence of bacterial resistance. Numerous studies and recommendations have been published on the prevention of VAPs. According to current recommendations, this prevention is based on a standardized multimodal approach, including systematic digestive decontamination (SDD) combining an enteral topical antiseptic and systemic antibiotic prophylaxis for less than 5 days to reduce mortality. However, the application of SDD remains limited, and few recent studies have focused on trauma patients. Recently, several studies and meta analysis showed a patential benefit of a single short course of systemic antibiotics (not full SDD) on the risk of subsequent VAP, especially in brain injured patients. The value of short-term antibiotic prophylaxis in trauma patients therefore remains to be documented. The aim of this study is to evaluate the impact of early antibiotic prophylaxis on the risk of VAP in a population of severe trauma patients.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- trauma, antibioprophylaxis, pneumonia, ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Wounds and Injuries, Pneumonia
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 |
|---|---|---|
| Early antibiotic prophylaxis group | Group will consist of patients meeting the inclusion criteria and : * in whom systemic intravenous antibiotic prophylaxis has been initiated within 24 hours of the start of medical management * with a duration of systemic antibiotic prophylaxis of between 24h and 72h | |
| Control group | The group will be made up of patients meeting the inclusion criteria and : - in whom no systemic antibiotic prophylaxis (apart from any intraoperative antibiotic prophylaxis) was administered during the first 72 hours after the start of medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
early onset ventilator associated pneumonia (VAP)
Incidence of early onset VAP (≤ 7 days after mechanical ventilation)
Measured: 28 days after ICU admission
Secondary outcomes (10)
incidence of VAP
Incidence of VAP, whatever the dely of occurrence
Measured: 28 days after ICU admission
Incidence of late onset VAP
Incidence of late onset VAP (>7 days after mecahnical ventilation)
Measured: 28 days after ICU admission
number of VAP
number of VAP during ICU stay
Measured: 28 days after ICU admission
Incidence of non-respiratory sepsis
Incidence of non-respiratory sepsis during ICU stay
Measured: 28 days after ICU admission
Incidence of surgical site infection
Incidence of surgical site infection during ICU stay
Measured: 28 days after ICU admission
acquisition of multidrug resistant bacteria
acquisition of MDR bacteria during ICU stay
Measured: 28 days after ICU admission
number of days with mechanical ventilation
Number of days with mechanical ventilation during ICU stay
Measured: 28 days after ICU admission
length of ICU stay
length of ICU stay
Measured: 28 days after ICU admission
length of hospital stay
length of hospital stay
Measured: 28 days after ICU admission
mortality at 28 days
mortality at 28 days
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Nov 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Foucrier, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059039
- Sponsor's protocol ID
- APHP240894
- Acronym
- antiVAP
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dahms K, Ansems K, Dormann J, Steinfeld E, Janka H, Metzendorf MI, Breuer T, Benstoem C. Effectiveness of antibiotic prophylaxis in polytrauma patients: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2025 Feb 13;51(1):105. doi: 10.1007/s00068-025-02789-8.
PubMed 39945862Hadley-Brown K, Hailstone L, Devane R, Chan T, Devaux A, Davis JS, Hammond N, Li Q, Litton E, Myburgh J, Poole A, Santos J, Seppelt I, Tong SYC, Udy A, Venkatesh B, Young PJ, Delaney AP. Prophylactic Antibiotics in Adults With Acute Brain Injury Who Are Invasively Ventilated in the ICU: A Systematic Review and Meta-Analysis. Chest. 2025 Apr;167(4):1079-1089. doi: 10.1016/j.chest.2024.10.031. Epub 2024 Oct 28.
PubMed 39490972Dahyot-Fizelier C, Lasocki S, Kerforne T, Perrigault PF, Geeraerts T, Asehnoune K, Cinotti R, Launey Y, Cottenceau V, Laffon M, Gaillard T, Boisson M, Aleyrat C, Frasca D, Mimoz O; PROPHY-VAP Study Group and the ATLANREA Study Group. Ceftriaxone to prevent early ventilator-associated pneumonia in patients with acute brain injury: a multicentre, randomised, double-blind, placebo-controlled, assessor-masked superiority trial. Lancet Respir Med. 2024 May;12(5):375-385. doi: 10.1016/S2213-2600(23)00471-X. Epub 2024 Jan 20.
PubMed 38262428
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibio Prophylaxis on Occurence of Ventilator Associated Pneumonia in Trauma Patients
- ClinicalTrials.gov ID
- NCT07059039
- Acronym / sponsor ID
- antiVAP / APHP240894
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- trauma, antibioprophylaxis, pneumonia, ventilator associated pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,143 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Jul 2025 (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.
The relevance of a short course of antibiotic prophylaxis for the prevention of ventilator assocaited pneumonia (VAP) in trauma patients, and its impact on bacterial ecology, remains to be clarified.
Antibiotics are often administered in the pre-hospital phase, usually in cases to traumatic lesions with high risk of secondary infection (open fractures, deteriorating wounds, etc.). If there is a potential benefit of such antibiotic prophylaxis on the risk of surgical site infection, there could also be a benefit on the risk of developing pulmonary infections. Recent data have shown a reduction in the risk of early-onset VAP in cerebrovascular patients with a strategy of very early administration of antibiotic prophylaxis (PROPHYVAP study(1)), as well as in patients taken into intensive care following cardiac arrest (ANTHARTIC study(2)). The aim of the study is to evaluate the impact of early systemic antibiotic prophylaxis in trauma patients on the incidence of early VAP during the ICU stay.
Detailed description
VAP is the most frequent infectious complication in the Intensive Care Units (ICU), with a higher incidence in trauma patients.
Individually, the development of VAP prolongs the duration of mechanical ventilation and in-hospital lenghts of stay, and is associated with additional costs. Collectively, VAP is responsible for around half of all antibiotic consumption in the ICU, with ecological consequences through the emergence of bacterial resistance. Numerous studies and recommendations have been published on the prevention of VAPs. According to current recommendations, this prevention is based on a standardized multimodal approach, including systematic digestive decontamination (SDD) combining an enteral topical antiseptic and systemic antibiotic prophylaxis for less than 5 days to reduce mortality. However, the application of SDD remains limited, and few recent studies have focused on trauma patients. Recently, several studies and meta analysis showed a patential benefit of a single short course of systemic antibiotics (not full SDD) on the risk of subsequent VAP, especially in brain injured patients. The value of short-term antibiotic prophylaxis in trauma patients therefore remains to be documented. The aim of this study is to evaluate the impact of early antibiotic prophylaxis on the risk of VAP in a population of severe trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early antibiotic prophylaxis group | – | –Group will consist of patients meeting the inclusion criteria and : * in whom systemic intravenous antibiotic prophylaxis has been initiated within 24 hours of the start of medical management * with a duration of systemic antibiotic prophylaxis of between 24h and 72h |
| Control group | – | –The group will be made up of patients meeting the inclusion criteria and : - in whom no systemic antibiotic prophylaxis (apart from any intraoperative antibiotic prophylaxis) was administered during the first 72 hours after the start of medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult trauma patients placed on mechanical ventilation during the first 24 hours of management, and for a duration of at least 48 hours
Key inclusion criteria (5 listed)
- Adult patient
- Trauma patient: admitted between 01/01/2021 and 31/12/2023 for suspected severe trauma (included in TraumaBase® )
- Put on mechanical ventilation during the first 24 hours following the start of medical care (including pre-hospital care)
- Patient on MV for at least 48 consecutive hours during intensive care stay
- Patient does not object to the use of his/her data for this research
Key exclusion criteria (2 listed)
- Patient under full selective digestive decontamination protocol
- Early inhaled antibiotic prophylaxis
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
early onset ventilator associated pneumonia (VAP)
Time frame: 28 days after ICU admission
Incidence of early onset VAP (≤ 7 days after mechanical ventilation)
10 secondary outcomes
incidence of VAP
Time frame: 28 days after ICU admission
Incidence of late onset VAP
Time frame: 28 days after ICU admission
number of VAP
Time frame: 28 days after ICU admission
Incidence of non-respiratory sepsis
Time frame: 28 days after ICU admission
Incidence of surgical site infection
Time frame: 28 days after ICU admission
acquisition of multidrug resistant bacteria
Time frame: 28 days after ICU admission
number of days with mechanical ventilation
Time frame: 28 days after ICU admission
length of ICU stay
Time frame: 28 days after ICU admission
length of hospital stay
Time frame: 28 days after ICU admission
mortality at 28 days
Time frame: 28 days after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publication: PubMed 39945862Dahms K, Ansems K, Dormann J, Steinfeld E, Janka H, Metzendorf MI, Breuer T, Benstoem C. Effectiveness of antibiotic prophylaxis in polytrauma patients: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2025 Feb 13;51(1):105. doi: 10.1007/s00068-025-02789-8.
- Results publication: PubMed 39490972Hadley-Brown K, Hailstone L, Devane R, Chan T, Devaux A, Davis JS, Hammond N, Li Q, Litton E, Myburgh J, Poole A, Santos J, Seppelt I, Tong SYC, Udy A, Venkatesh B, Young PJ, Delaney AP. Prophylactic Antibiotics in Adults With Acute Brain Injury Who Are Invasively Ventilated in the ICU: A Systematic Review and Meta-Analysis. Chest. 2025 Apr;167(4):1079-1089. doi: 10.1016/j.chest.2024.10.031. Epub 2024 Oct 28.
- Results publication: PubMed 38262428Dahyot-Fizelier C, Lasocki S, Kerforne T, Perrigault PF, Geeraerts T, Asehnoune K, Cinotti R, Launey Y, Cottenceau V, Laffon M, Gaillard T, Boisson M, Aleyrat C, Frasca D, Mimoz O; PROPHY-VAP Study Group and the ATLANREA Study Group. Ceftriaxone to prevent early ventilator-associated pneumonia in patients with acute brain injury: a multicentre, randomised, double-blind, placebo-controlled, assessor-masked superiority trial. Lancet Respir Med. 2024 May;12(5):375-385. doi: 10.1016/S2213-2600(23)00471-X. Epub 2024 Jan 20.
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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. This study is not recruiting at the moment.
Arnaud Foucrier, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia ( VAP), run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 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: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early onset ventilator associated pneumonia (VAP) (time frame: 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07059039, which also lists 3 linked publications.
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 10 Sep 2025.