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

NCT07059039 | Completed

• 1 other identifier: APHP240894
• Study Type: observational
• Target: 2,143
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

trauma; antibioprophylaxis; pneumonia; ventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

• early onset ventilator associated pneumonia (VAP)

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

  28 days after ICU admission

Secondary Outcomes (10)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Beaujon

Clichy, 92110, France

Location

Related Publications (3)

• 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.

  PMID: 39945862 BACKGROUND

• Hadley-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.

  PMID: 39490972 BACKGROUND

• Dahyot-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.

  PMID: 38262428 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Wounds and Injuries; Pneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Foucrier, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-07

Locations

FR (1)