PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone

Phase 3

Completed

• Conditions: Early Ventilation Acquired Pneumonia in Brain Injured Patients
• Interventions: Drug: Anti-Infective Agents; Drug: Placebo

• Registration Number: NCT02265406
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position \>= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.

Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-15
• Study Start: 2015-10
• Primary Completion: 2020-07-25
• Study Completion: 2020-07-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours

Exclusion Criteria

• Patient with a high risk of death within the 48 first hours after admission,
• Patient intubated for more than12 hours
• Intubation after the 48th hours after admission
• Coverage to cardiopulmonary arrest
• Coma due to a tumor, an infectious disease or a cardiac arrest
• Previous hospitalisation within the last month before admission for coma
• béta-lactamines allergy
• Patient who receive already antibiotics at the admission for a previous infection
• Prophylactic antibiotic due to be done within 24 hours following the randomisation
• Patient Intubated through a tracheal tube with subglottic secretion aspiration
• Patient with a tracheotomy
• Patient or family refuse to be involved in the study
• Use of Ceftriaxone within 2 days before enrolment
• Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection
• Patients not affiliated to a social security scheme, Pregnant woman or breast-feeding mother, Patients deprived of their liberty by judicial or administrative decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftriaxone	Anti-Infective Agents	-
Sodium Chloride	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of early VAP, proportion of patients who develop a VAP within the 7 first day after mechanical ventilation (the 7th day included), confirm with microbiological culture, within all included patients.	30 months

Secondary Outcome Measures

Name	Time	Method
- Incidence of late VAP (> 7 jours)	30 months
- Global incidence of VAP during intensive care period (limited to day 60)	30 months
- Type of bacteria and their sensitivity for early or late VAP,	30 months
- Time between inclusion and occurence of the first VAP (limited to day 28),	30 months
- Length of stay in intensive care unit, limited to 60 days,	30 months
- Length of stay at the hospital, limited to 60 days,	30 months
- Mortality at day 28 and 60.	30 months
- Length of the first period of mechanical ventilation during the intensive care period,	30 months
- Time between inclusion and the first spontaneous ventilation test (limited to day 28),	30 months
- Length of antibiotherapy during intensive care period,	30 months
- Length of intensive care, limited to 60 days,	30 months
- Incidence of ventilated associated event (limited to day 60)	30 months
- Neurological prognosis at the discharge of the intensive care unit,	30 months
- Comparison of the global incidence of VAP according to the diagnosis defined by "American Thoracic Society" or by "Centers for Disease Control"	30 months

Trial Locations

Locations (8)

CHU; 🇫🇷 Bordeaux, France

University Hospital of Poitiers; 🇫🇷 Poitiers, France

University Hospital of Nantes; 🇫🇷 Nantes, France

University Hospital of Rennes; 🇫🇷 Rennes, France

Thomas GEERAERTS; 🇫🇷 Toulouse, France

Djilali ELAROUSSI; 🇫🇷 Tours, France

University Hospital of Angers; 🇫🇷 Angers, France

CHRU; 🇫🇷 Montpellier, France