Accéder directement au contenu Accéder directement à la navigation
Article dans une revue

Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

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.
Type de document :
Article dans une revue
Liste complète des métadonnées

https://hal.sorbonne-universite.fr/hal-03371249
Contributeur : Gestionnaire Hal-Su Connectez-vous pour contacter le contributeur
Soumis le : vendredi 8 octobre 2021 - 14:36:07
Dernière modification le : mercredi 24 novembre 2021 - 17:48:03

Fichier

e048591.full.pdf
Publication financée par une institution

Licence


Distributed under a Creative Commons Paternité - Pas d'utilisation commerciale 4.0 International License

Identifiants

Citation

Elsa Tavernier, Francois Barbier, Ferhat Meziani, Jean-Pierre Quenot, Jean-Etienne Herbrecht, et al.. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol. BMJ Open, BMJ Publishing Group, 2021, 11 (9), 10 p. ⟨10.1136/bmjopen-2020-048591⟩. ⟨hal-03371249⟩

Partager

Métriques

Consultations de la notice

59

Téléchargements de fichiers

50