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Prevention of early ventilation-acquired pneumonia (VAP) in comatose brain-injured patients by a single dose of ceftriaxone: PROPHY-VAP study protocol, a multicentre, randomised, double-blind, placebo-controlled trial
  1. Claire Dahyot-Fizelier1,2,
  2. Denis Frasca1,3,
  3. Sigismond Lasocki4,
  4. Karim Asehnoune5,
  5. Dorothée Balayn1,
  6. Anne-Laure Guerin1,
  7. Pierre-François Perrigault6,
  8. Thomas Geeraerts7,
  9. Philippe Seguin8,
  10. Bertrand Rozec5,
  11. Djilali Elaroussi9,
  12. Vincent Cottenceau10,
  13. Clément Guyonnaud1,
  14. Olivier Mimoz2,11
  15. For the PROPHY-VAP Study group, ATLANREA group
    1. 1 Anesthesia and Intensive Care, University Hospital of Poitiers, Poitiers, France
    2. 2 INSERM UMR1070 – Pharmacology of Anti-infective Agents, University of Poitiers, Poitiers, France
    3. 3 INSERM UMR1246 – Methods in Patient-Centered Outcomes and Health Research, Nantes, France
    4. 4 Anesthesia and Intensive Care, University Hospital of Angers, Angers, France
    5. 5 Anesthesia and Intensive Care Unit, University Hospital of Nantes, Nantes, France
    6. 6 Anesthesia and Intensive Care Unit, University Hospital of Montpellier, Montpellier, France
    7. 7 Anesthesia and Intensive Care Unit, University Hospital of Toulouse, Toulouse, France
    8. 8 Anesthesia and Intensive Care Unit, University Hospital of Rennes, Rennes, France
    9. 9 Anesthesia and Intensive Care Unit, University Hospital of Tours, Tours, France
    10. 10 Anesthesia and Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France
    11. 11 Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France
    1. Correspondence to Professor Claire Dahyot-Fizelier; claire.dahyot{at}gmail.com

    Abstract

    Introduction Ventilator-associated pneumonia (VAP) is the first cause of healthcare-associated infections in intensive care units (ICUs) and brain injury is one of the main risk factors for early-onset VAP. Antibiotic prophylaxis has been reported to decrease their occurrence in brain-injured patients, but a lack of controlled randomised trials and the risk of induction of bacterial resistance explain the low level of recommendations. The goal of this study is to determine whether a single dose of ceftriaxone within the 12 hours postintubation after severe brain injury can decrease the risk of early-onset VAP.

    Methods and analysis The PROPHY-VAP is a French multicentre, randomised, double-blind, placebo-controlled, clinical trial. Adult brain-injured patients (n=320) with a Glasgow Coma Scale ≤12, requiring mechanical ventilation for more than 48 hours, are randomised to receive either a single dose of ceftriaxone 2 g or a placebo within the 12 hours after tracheal intubation. The primary endpoint is the proportion of patients developing VAP from the 2nd to the 7th day after mechanical ventilation. Secondary endpoints include the proportion of patients developing late VAP (>7 days after tracheal intubation), the number of ventilator-free days, VAP-free days and antibiotic-free days, length of stay in the ICU, proportion of patients with ventilator-associated events and mortality during their ICU stay.

    Ethics and dissemination The initial research project was approved by the Institutional Review Board of OUEST III (France) on 20 October 2014 (registration No 2014-001668-36) and carried out according to the principles of the Declaration of Helsinki and the Clinical Trials Directive 2001/20/EC of the European Parliament relating to the Good Clinical Practice guidelines. The results of this study will be presented in national and international meetings and published in an international peer-reviewed journal.

    Trial registration number NCT02265406; Pre-results.

    • ventilator-associated pneumonia
    • brain-injured patient
    • ceftriaxone
    • prophylaxis

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    Footnotes

    • Contributors CD-F conceived the study, coordinated its design and drafted the manuscript. CD-F and OM wrote the manuscript. SL, KA, P-FP, TG, PS, BR, DE, VC, CG, DB and A-LG read and were involved in critical appraisal and revision of the manuscript. DF provided statistical expertise. All authors approved the final manuscript prior to submission.

    • Funding This work was supported by a grant from the French Ministry of Social Affairs and Health under number PHRC-13-062.

    • Disclaimer Funder will have no role in the study’s conception or in data analysis.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The initial research project was approved by the institutional Review Board of OUEST III (France) on 20 October 2014 (registration No 2014-001668-36).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators For thePROPHY-VAP Study group: ATLANREA group Didier Baudouin, Rémy Bellier, Thierry Benard, Elsa Carise, Raphaël Cinotti, Adriana Roxana Donisanu, Rémi Drilleau, Eric Fournier, Thomas Gaillard, Anne-Emmanuelle Gaufichon, Benoit Giraud, Nadia Imzi, Nathalie Klein, Marc Laffon, Raphaëlle Larmet, Yannick Malledant, Ségolène Mrozec, Hodanou Nanadoumgar, Thibaut Papet, Franck Petitpas, Amélie Pichot, Bénédicte Pontier, Antoine Roquilly, Sabrina Seguin.

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