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Clinical Trials/NCT07059039
NCT07059039CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country2,143 target enrollmentStarted: November 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,143
Locations
1
Primary Endpoint
early onset ventilator associated pneumonia (VAP)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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

  • incidence of VAP(28 days after ICU admission)
  • Incidence of late onset VAP(28 days after ICU admission)
  • number of VAP(28 days after ICU admission)
  • Incidence of non-respiratory sepsis(28 days after ICU admission)
  • Incidence of surgical site infection(28 days after ICU admission)
  • length of hospital stay(28 days after ICU admission)
  • acquisition of multidrug resistant bacteria(28 days after ICU admission)
  • number of days with mechanical ventilation(28 days after ICU admission)
  • length of ICU stay(28 days after ICU admission)
  • mortality at 28 days(28 days after ICU admission)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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