1. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol
- Author
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Sigismond Lasocki, Claire Dahyot-fizelier, Benoit Veber, Damien Roux, Stephan Ehrmann, Jean-Pierre Quenot, Thierry Boulain, Mai-Anh Nay, Elsa Tavernier, Gaetan Beduneau, Philippe Seguin, Jean-Claude Lacherade, Grégoire Muller, Maria Cabrera, Gaetan Plantefeve, Mickael Landais, Nicolas Grégoire, Francois Barbier, Ferhat Meziani, Jean-Etienne Herbrecht, David Schnell, Anne Veinstein, Qin Lu, Martine Ferrandiere, Hamid Merdji, Pascal Andreu, Laurent Vecellio, Deborah Le Pennec, Renaud Respaud, Philippe Lanotte, Marie Leclerc, and Julie Helms
- Subjects
Medicine - Abstract
Introduction Pre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.Methods and analysis Academic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee.Ethics and dissemination The protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals.Trial registration numbers EudraCT 2016-001054-17 and NCT03149640.
- Published
- 2021
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