Key result
Ongoing RODEO trials test if oral antibiotics are non-inferior to IV therapy for left-sided endocarditis.
Why the study?
Oral switch after initial intravenous antibiotic therapy for left-sided infective endocarditis may reduce costs and patient discomfort without increasing unfavourable outcomes, but non-inferiority to entirely intravenous therapy needs evaluation.
Does switching to oral antibiotic therapy after initial intravenous therapy prevent treatment failure in patients with left-sided infective endocarditis?
RCT (n=648)
Open-label
Yes
Does switching to oral antibiotic therapy after initial intravenous therapy prevent treatment failure in patients with left-sided infective endocarditis?
This protocol describes two randomized trials assessing the non-inferiority of switching to oral antibiotics versus continuing intravenous therapy for left-sided infective endocarditis.
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.
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Lemaignen et al. (2020) conducted an RCT in Left-sided infective endocarditis (n=648). Oral antibiotic therapy (oral switch) vs. Entirely intravenous antibiotic therapy was evaluated on Treatment failure within 3 months after the end of antibiotic treatment (composite of all-cause death, symptomatic embolic events, unplanned valvular surgery, and/or microbiological relapse). The RODEO trials are ongoing randomized protocols designed to evaluate if switching to oral antibiotics is non-inferior (10% margin) to continued intravenous therapy for left-sided endocarditis.
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