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

Author

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

Author

Jean-Pierre Quenot, Nicolas Grégoire, Stephan Ehrmann, Mai-Anh Nay, Benoit Veber, François Barbier, Jean-Claude Lacherade, Qin Lu, Grégoire Muller, Thierry Boulain, Julie Helms, Marie Leclerc, Pascal Andreu, Gaëtan Plantefève, Deborah Le Pennec, Renaud Respaud, Claire Dahyot-Fizelier, Elsa Tavernier, Martine Ferrandière, Gaetan Beduneau, Laurent Vecellio, Anne Veinstein, Philippe Seguin, Maria Cabrera, Hamid Merdji, David Schnell, Jean-Etienne Herbrecht, Damien Roux, Sigismond Lasocki, Ferhat Meziani, Philippe Lanotte, Mickael Landais, Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional d'Orléans (CHRO), Les Hôpitaux Universitaires de Strasbourg (HUS), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Le Mans (CH Le Mans), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], Centre Hospitalier d'Angoulême (CH Angoulême), Centre hospitalier universitaire de Poitiers (CHU Poitiers), CHU Rouen, Normandie Université (NU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre Hospitalier Victor Dupouy, Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Infectiologie et Santé Publique (UMR ISP), Université de Tours-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Départemental Vendée (CHDV), University Hospital of Tours, France, Programme Hospitalier de Recherche Clinique National 2015 of the French Ministry of Health (PHRC-15-260), Association pour la promotion à Tours de la Réanimation Médicale, HAL-SU, Gestionnaire, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Tours (UT)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
medicine.medical_specialty, medicine.medical_treatment, infectious diseases, Placebo, law.invention, respiratory infections, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, Informed consent, law, Administration, Inhalation, medicine, Humans, Multicenter Studies as Topic, Amikacin, adult intensive & critical care, Randomized Controlled Trials as Topic, Mechanical ventilation, clinical trials, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Intensive Care, Ventilator-associated pneumonia, Pneumonia, Ventilator-Associated, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Respiration, Artificial, 3. Good health, Clinical trial, Pneumonia, Treatment Outcome, 030228 respiratory system, Emergency medicine, Medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, medicine.drug
Abstract

IntroductionPre-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 analysisAcademic, 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 disseminationThe 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 numbersEudraCT 2016-001054-17 and NCT03149640.

Published
2021
Full Text
View/download PDF

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