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

Last updated: July 1, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT07059039
APHP240894
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient

  • Trauma patient: admitted between 01/01/2021 and 31/12/2023 for suspected severetrauma (included in TraumaBase® )

  • Put on mechanical ventilation during the first 24 hours following the start ofmedical 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

Exclusion Criteria:

  • Patient under full selective digestive decontamination protocol

  • Antibiotic prophylaxis lasting ≥ 72h

  • Early inhaled antibiotic prophylaxis

Study Design

Total Participants: 3500
Study Start date:
November 01, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Hopital Beaujon

    Clichy, 92110
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.