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

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ClinicalTrials.gov Identifier: NCT02265406
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Early Ventilation Acquired Pneumonia in Brain Injured Patients Drug: Anti-Infective Agents Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 25, 2020
Actual Study Completion Date : July 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Ceftriaxone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceftriaxone Drug: Anti-Infective Agents
Placebo Comparator: Sodium Chloride Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. - Incidence of late VAP (> 7 jours) [ Time Frame: 30 months ]
  2. - Global incidence of VAP during intensive care period (limited to day 60) [ Time Frame: 30 months ]
  3. - Type of bacteria and their sensitivity for early or late VAP, [ Time Frame: 30 months ]
  4. - Time between inclusion and occurence of the first VAP (limited to day 28), [ Time Frame: 30 months ]
  5. - Length of the first period of mechanical ventilation during the intensive care period, [ Time Frame: 30 months ]
  6. - Time between inclusion and the first spontaneous ventilation test (limited to day 28), [ Time Frame: 30 months ]
  7. - Length of antibiotherapy during intensive care period, [ Time Frame: 30 months ]
  8. - Length of intensive care, limited to 60 days, [ Time Frame: 30 months ]
  9. - Length of stay in intensive care unit, limited to 60 days, [ Time Frame: 30 months ]
  10. - Length of stay at the hospital, limited to 60 days, [ Time Frame: 30 months ]
  11. - Neurological prognosis at the discharge of the intensive care unit, [ Time Frame: 30 months ]
  12. - Mortality at day 28 and 60. [ Time Frame: 30 months ]
  13. - Incidence of ventilated associated event (limited to day 60) [ Time Frame: 30 months ]
  14. - Comparison of the global incidence of VAP according to the diagnosis defined by "American Thoracic Society" or by "Centers for Disease Control" [ Time Frame: 30 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265406


Locations
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France
University Hospital of Angers
Angers, France, 49933
CHU
Bordeaux, France
CHRU
Montpellier, France
University Hospital of Nantes
Nantes, France, 44093
University Hospital of Poitiers
Poitiers, France, 86021
University Hospital of Rennes
Rennes, France, 35033
Thomas GEERAERTS
Toulouse, France, 31059
Djilali ELAROUSSI
Tours, France, 37000
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02265406    
Other Study ID Numbers: PROPHY-VAP
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
 Lung Diseases
Respiratory Tract Diseases
Anti-Infective Agents