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Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol.
Tavernier, Elsa; Barbier, Francois; Meziani, Ferhat; Quenot, Jean-Pierre; Herbrecht, Jean-Etienne; Landais, Mickael; Roux, Damien; Seguin, Philippe; Schnell, David; Veinstein, Anne; Veber, Benoît; Lasocki, Sigismond; Lu, Qin; Beduneau, Gaetan; Ferrandiere, Martine; Dahyot-Fizelier, Claire; Plantefeve, Gaetan; Nay, Mai-Anh; Merdji, Hamid; Andreu, Pascal; Vecellio, Laurent; Muller, Grégoire; Cabrera, Maria; Le Pennec, Deborah; Respaud, Renaud; Lanotte, Philippe; Gregoire, Nicolas; Leclerc, Marie; Helms, Julie; Boulain, Thierry; Lacherade, Jean-Claude; Ehrmann, Stephan.
  • Tavernier E; Inserm CIC 1415, CHRU Tours, Tours, France.
  • Barbier F; Médecine Intensive Réanimation, CHR d'Orléans, Orleans, France.
  • Meziani F; Service de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
  • Quenot JP; Department of Intensive Care, Lipness Team, INSERM Research Centre LNC-UMR1231, LabExLipSTIC, and INSERM CIC 1432, Clinical Epidemiology, François Mitterrand University Hospital, University of Burgundy, Dijon, France.
  • Herbrecht JE; Médecine Intensive Réanimation, Hôpital Hautepierre, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
  • Landais M; Réanimation médico-chirurgicale, CH du Mans, Le Mans, France.
  • Roux D; Médecine Intensive Réanimation, Hôpital Louis Mourier, Assistance Publique - Hopitaux de Paris, Colombes, France.
  • Seguin P; Réanimation Chirurgicale, CHU Rennes, Rennes, France.
  • Schnell D; Réanimation Polyvalente, CH Angouleme, Angouleme, France.
  • Veinstein A; Médecine Intensive Réanimation, CHU de Poitiers, Poitiers, France.
  • Veber B; Réanimation Chirurgicale, CHU de Rouen, Université de Rouen Normandie, Rouen, France.
  • Lasocki S; Réanimation Chirurgicale, CHU Angers, Angers, France.
  • Lu Q; Multidisciplinary Critical Care Unit, Department of Anaesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.
  • Beduneau G; Medical Intensive Care Unit, EA 3830, Normandie Université, UNIROUEN, Rouen University Hospital, Rouen, France.
  • Ferrandiere M; Réanimation Chirurgicale, CHRU Tours, Tours, France.
  • Dahyot-Fizelier C; Réanimation Chirurgicale, CHRU de Poitiers, Poitiers, France.
  • Plantefeve G; Réanimation Polyvalente et Unité de Surveillance Continue, CH Victor Dupouy, Argenteuil, France.
  • Nay MA; Médecine Intensive Réanimation, CHR d'Orléans, Orleans, France.
  • Merdji H; Service de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
  • Andreu P; Department of Intensive Care, Lipness Team, INSERM Research Centre LNC-UMR1231, LabExLipSTIC, and INSERM CIC 1432, Clinical Epidemiology, François Mitterrand University Hospital, University of Burgundy, Dijon, France.
  • Vecellio L; Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
  • Muller G; Médecine Intensive Réanimation, CHR d'Orléans, Orleans, France.
  • Cabrera M; Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
  • Le Pennec D; Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
  • Respaud R; Pharmacie, Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, CHRU de Tours, Faculté de médecine, Université de Tours, Tours, France.
  • Lanotte P; Service de Bactériologie-Virologie, INRAE, ISP, CHRU de Tours, Université de Tours, Tours, France.
  • Gregoire N; INSERM UMR S1070, Laboratoire pharmacologie des anti-infectieux; Laboratoire de toxicologie-phamacologie, Université de Poitiers; CHU de Poitiers, Poitiers, France.
  • Leclerc M; Délégation à la Recherche Clinique et à l'Innovation, CHRU Tours, Tours, France.
  • Helms J; Service de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
  • Boulain T; Médecine Intensive Réanimation, CHR d'Orléans, Orleans, France.
  • Lacherade JC; Médecine Intensive Réanimation, CHD de Vendée, La Roche-sur-Yon, France.
  • Ehrmann S; Médecine Intensive Réanimation, CIC 1415, Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, CHRU de Tours, Faculté de médecine, Université de Tours, Tours, France stephan.ehrmann@univ-tours.fr.
BMJ Open ; 11(9): e048591, 2021 09 14.
Article in English | MEDLINE | ID: covidwho-1495462
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Amikacin / Pneumonia, Ventilator-Associated Type of study: Controlled clinical trial / Clinical Practice Guide / Randomized controlled trials / Reviews / Risk factors Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-048591

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Amikacin / Pneumonia, Ventilator-Associated Type of study: Controlled clinical trial / Clinical Practice Guide / Randomized controlled trials / Reviews / Risk factors Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-048591