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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Ventilator Associated Pneumonia ( VAP)

Study type: Observational

Funder types: Other

Identifiers

NCT07059039

APHP240894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,143 participants in 2 patient groups

Early antibiotic prophylaxis group

Description:

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

Description:

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