About: Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials

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About: Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials
Creator	Tattevin, Pierre Duval, Xavier Strady, Christophe Hoen, Bruno Pompidou, Georges Adrien, Carvalho-Schneider Alla, François Beraud, Guillaume Bernard, Louis Bru, Jean-Pierre Brunet-Houdard, Solène Caille, Agnès Chirouze, Catherine Claudia, Bastides Delahaye, Francois Frédéric, Hallouin-Bernard Goehringer, Francois Jean-Luc, Mainardi Lemaignen, Adrien Mainardi, Jean-Luc Louis, Lemaignen Selton-Suty, Christine
Source	Medline; PMC
abstract	INTRODUCTION: Left-sided infective endocarditis (IE) is a serious infection with a heavy burden for patients and healthcare system. Oral switch after initial intravenous antibiotic therapy may reduce costs and improve patients’ discomfort without increasing unfavourable outcomes. We describe the methodology of two simultaneously conducted open-label randomised trials aiming to assess non-inferiority of oral switch as compared with entirely intravenous antibiotic therapy for the treatment of left-sided IE. METHODS AND ANALYSIS: Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing. One trial is dedicated to left-sided IE caused by multisusceptible staphylococci (Relais Oral Dans le traitement des Endocardites à staphylocoques ou streptOcoques (RODEO)-1) and the other is dedicated to left-sided IE caused by susceptible streptococci or enterococci (RODEO-2). It is planned to randomise 324 patients in each trial after an initial course of at least 10 days of intravenous antibiotic therapy either to continue intravenous antibiotic therapy or to switch to oral antibiotic therapy. The primary outcome is treatment failure within 3 months after the end of antibiotic treatment, a composite outcome defined by all-cause death and/or symptomatic embolic events and/or unplanned valvular surgery and/or microbiological relapse (with the primary pathogen). Secondary outcomes include patient quality of life, echocardiographic outcome, costs and efficiency associated with IE care. Statistical analysis will be performed with a non-inferiority margin of 10% and a one-sided 2.5% type I error. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2015-R26, 23 February 2016). Study findings will be published in peer-reviewed journals and disseminated through presentation at relevant national and international conferences. TRIAL REGISTRATION NUMBER: EudraCT Number: 2015-002371-16 and NCT02701608; NCT02701595.
has issue date	2020-07-14(xsd:dateTime)
bibo:doi	10.1136/bmjopen-2019-033540
bibo:pmid	32665381
has license	cc-by-nc
sha1sum (hex)	7add6802177c2ab0009aaa215c968fd802111c4b
schema:url	https://doi.org/10.1136/bmjopen-2019-033540
resource representing a document's title	Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials
has PubMed Central identifier	PMC7365486
has PubMed identifier	32665381
schema:publication	BMJ Open
resource representing a document's body	covid:7add6802177c2ab0009aaa215c968fd802111c4b#body_text
is schema:about of	named entity 'open-label' named entity 'protocol' named entity 'antibiotic' named entity 'switch' named entity 'streptococci' named entity 'intravenous' named entity 'Left-sided' named entity 'enterococci' named entity 'CONSORT Statement' named entity 'resistant bacteria' named entity 'antibiotic treatment' named entity 'antibiotic therapy' named entity 'infection' named entity 'Clinical research' named entity 'embolic' named entity 'risk factor' named entity '8th amendment' named entity 'Safety Monitoring' named entity 'intravenous' named entity 'staphylococci' named entity 'valvular surgery' named entity 'infective endocarditis' named entity 'diffusion' named entity 'enterococci' named entity 'pharmacy' named entity 'statistical analysis' named entity 'antibiotic' named entity 'antibiotic therapy' named entity 'diffusion' named entity 'case report form' named entity 'hospital discharge' named entity 'animal experiments' named entity 'antibiotic treatment' named entity 'abscess' named entity 'left-sided' named entity 'echocardiographic' named entity 'rifampicin' named entity 'Infective endocarditis' named entity 'ITT' named entity 'informed consent' named entity 'valvular surgery' named entity 'research ethics committee' named entity 'symptom' named entity 'intravenous' named entity 'infective endocarditis' named entity 'antibiotic therapy' named entity 'streptococci' named entity 'economic evaluation' named entity 'sensitivity analysis' named entity 'cost-utility analysis' named entity 'antibiotic treatment' named entity 'antibiotic' named entity 'risk factor' named entity 'antibiotic treatment' named entity 'primary care' named entity 'informed consent' named entity 'left-sided' named entity 'France' named entity 'statistical power' named entity 'economic evaluation'

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