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Impact of Antibio Prophylaxis on Occurence of Ventilator Associated Pneumonia in Trauma Patients

Impact of Antibio Prophylaxis on Occurence of Ventilator Associated Pneumonia in Trauma Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07059039
Acronym
antiVAP
Enrollment
2143
Registered
2025-07-10
Start date
2024-11-01
Completion date
2025-07-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

trauma, antibioprophylaxis, pneumonia, ventilator associated pneumonia

Brief 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. 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patient under full selective digestive decontamination protocol * Early inhaled antibiotic prophylaxis

Design outcomes

Primary

MeasureTime frameDescription
early onset ventilator associated pneumonia (VAP)28 days after ICU admissionIncidence of early onset VAP (≤ 7 days after mechanical ventilation)

Secondary

MeasureTime frameDescription
length of ICU stay28 days after ICU admissionlength of ICU stay
length of hospital stay28 days after ICU admissionlength of hospital stay
mortality at 28 days28 days after ICU admissionmortality at 28 days
acquisition of multidrug resistant bacteria28 days after ICU admissionacquisition of MDR bacteria during ICU stay
number of days with mechanical ventilation28 days after ICU admissionNumber of days with mechanical ventilation during ICU stay
Incidence of late onset VAP28 days after ICU admissionIncidence of late onset VAP (\>7 days after mecahnical ventilation)
number of VAP28 days after ICU admissionnumber of VAP during ICU stay
Incidence of non-respiratory sepsis28 days after ICU admissionIncidence of non-respiratory sepsis during ICU stay
Incidence of surgical site infection28 days after ICU admissionIncidence of surgical site infection during ICU stay
incidence of VAP28 days after ICU admissionIncidence of VAP, whatever the dely of occurrence

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026