Status:
COMPLETED
PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone
Lead Sponsor:
Poitiers University Hospital
Conditions:
Early Ventilation Acquired Pneumonia in Brain Injured Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2020
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT02265406
Start Date
October 1 2015
End Date
July 25 2020
Last Update
February 3 2021
Active Locations (8)
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1
University Hospital of Angers
Angers, France, 49933
2
CHU
Bordeaux, France
3
CHRU
Montpellier, France
4
University Hospital of Nantes
Nantes, France, 44093