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Completed

NCT Number: NCT07059039

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. early onset ventilator associated pneumonia (VAP)

    Time frame: 28 days after ICU admission

    Incidence of early onset VAP (≤ 7 days after mechanical ventilation)

Secondary outcomes

  1. incidence of VAP

    Time frame: 28 days after ICU admission

    Incidence of VAP, whatever the dely of occurrence

  2. Incidence of late onset VAP

    Time frame: 28 days after ICU admission

    Incidence of late onset VAP (>7 days after mecahnical ventilation)

  3. number of VAP

    Time frame: 28 days after ICU admission

    number of VAP during ICU stay

  4. Incidence of non-respiratory sepsis

    Time frame: 28 days after ICU admission

    Incidence of non-respiratory sepsis during ICU stay

  5. Incidence of surgical site infection

    Time frame: 28 days after ICU admission

    Incidence of surgical site infection during ICU stay

  6. acquisition of multidrug resistant bacteria

    Time frame: 28 days after ICU admission

    acquisition of MDR bacteria during ICU stay

  7. number of days with mechanical ventilation

    Time frame: 28 days after ICU admission

    Number of days with mechanical ventilation during ICU stay

  8. length of ICU stay

    Time frame: 28 days after ICU admission

    length of ICU stay

  9. length of hospital stay

    Time frame: 28 days after ICU admission

    length of hospital stay

  10. mortality at 28 days

    Time frame: 28 days after ICU admission

    mortality at 28 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: antiVAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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