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. Issue 10 (18th October 2018)

• Record Type: Journal Article
• Authors: Dahyot-Fizelier, Claire; Frasca, Denis; Lasocki, Sigismond; Asehnoune, Karim; Balayn, Dorothée; Guerin, Anne-Laure; Perrigault, Pierre-François; Geeraerts, Thomas; Seguin, Philippe; Rozec, Bertrand; Elaroussi, Djilali; Cottenceau, Vincent; Guyonnaud, Clément; Mimoz, Olivier
• Other Names: author non-byline.; Baudouin Didier author non-byline.; Bellier Rémy author non-byline.; Benard Thierry author non-byline.; Carise Elsa author non-byline.; Cinotti Raphaël author non-byline.; Donisanu Adriana Roxana author non-byline.; Drilleau Rémi author non-byline.; Fournier Eric author non-byline.; Gaillard Thomas author non-byline.; Gaufichon Anne-Emmanuelle author non-byline.; Giraud Benoit author non-byline.; Imzi Nadia author non-byline.; Klein Nathalie author non-byline.; Laffon Marc author non-byline.; Larmet Raphaëlle author non-byline.; Malledant Yannick author non-byline.; Mrozec Ségolène author non-byline.; Nanadoumgar Hodanou author non-byline.; Papet Thibaut author non-byline.; Petitpas Franck author non-byline.; Pichot Amélie author non-byline.; Pontier Bénédicte author non-byline.; Roquilly Antoine author non-byline.; Seguin Sabrina author non-byline.
• Is Part Of: BMJ open. Volume 8:Issue 10(2018)
• Publication Date: 2018-10-18
• Subjects: ventilator-associated pneumonia -- brain-injured patient -- ceftriaxone -- prophylaxis; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-021488
• Languages: English
• ISSNs: 2044-6055

Abstract

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.