Kasper Iversen1, Nikolaj Ihlemann1, Sabine U Gill1, Trine Madsen1, Hanne Elming1, Kaare T Jensen1, Niels E Bruun1, Dan E Høfsten1, Kurt Fursted1, Jens J Christensen1, Martin Schultz1, Christine F Klein1, Emil L Fosbøll1, Flemming Rosenvinge1, Henrik C Schønheyder1, Lars Køber1, Christian Torp-Pedersen1, Jannik Helweg-Larsen1, Niels Tønder1, Claus Moser1, Henning Bundgaard1. 1. From the Department of Cardiology, Herlev-Gentofte University Hospital (K.I., M.S., C.F.K.), Department of Cardiology, the Heart Center, Rigshospitalet, Copenhagen University Hospital (N.I., D.E.H., E.L.F., L.K., H.B.), the Departments of Infectious Diseases (J.H.-L.) and Clinical Microbiology (C.M.), Rigshospitalet, the Department of Cardiology, Hillerød Hospital (N.T.), and the Department of Clinical Microbiology, Slagelse Hospital and Institute of Clinical Medicine (J.J.C.), University of Copenhagen, Copenhagen, the Departments of Cardiology (S.U.G.) and Clinical Microbiology (F.R.), Odense University Hospital, Odense, the Departments of Cardiology (T.M.) and Cardiology and Epidemiology and Biostatistics (C.T.-P.), Aalborg University Hospital, the Department of Clinical Microbiology, Aalborg University Hospital, Aalborg University (H.C.S.), and the Department of Health Science and Technology, Aalborg University (C.T.-P.), Aalborg, the Department of Cardiology, Zealand University Hospital, Roskilde (H.E.), the Department of Cardiology, Aarhus University Hospital, Aarhus (K.T.J.), the Department of Cardiology, University Hospital of Copenhagen, Gentofte (N.E.B.), and the Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen (K.F.) - all in Denmark.
Abstract
BACKGROUND:Patients with infective endocarditis on the left side of the heart are typically treated withintravenous antibiotic agents for up to 6 weeks. Whether a shift from intravenous to oral antibiotics once the patient is in stable condition would result in efficacy and safety similar to those with continued intravenous treatment is unknown. METHODS: In a randomized, noninferiority, multicenter trial, we assigned 400 adults in stable condition who had endocarditis on the left side of the heart caused by streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci and who were being treated with intravenous antibiotics to continue intravenous treatment (199 patients) or to switch to oral antibiotic treatment (201 patients). In all patients, antibiotic treatment was administered intravenously for at least 10 days. If feasible, patients in the orally treated group were discharged to outpatient treatment. The primary outcome was a composite of all-cause mortality, unplanned cardiac surgery, embolic events, or relapse of bacteremia with the primary pathogen, from the time of randomization until 6 months after antibiotic treatment was completed. RESULTS: After randomization, antibiotic treatment was completed after a median of 19 days (interquartile range, 14 to 25) in the intravenously treated group and 17 days (interquartile range, 14 to 25) in the orally treated group (P=0.48). The primary composite outcome occurred in 24 patients (12.1%) in the intravenously treated group and in 18 (9.0%) in the orally treated group (between-group difference, 3.1 percentage points; 95% confidence interval, -3.4 to 9.6; P=0.40), which met noninferiority criteria. CONCLUSIONS: In patients with endocarditis on the left side of the heart who were in stable condition, changing to oral antibiotic treatment was noninferior to continued intravenous antibiotic treatment. (Funded by the Danish Heart Foundation and others; POET ClinicalTrials.gov number, NCT01375257 .).
RCT Entities:
BACKGROUND:Patients with infective endocarditis on the left side of the heart are typically treated with intravenous antibiotic agents for up to 6 weeks. Whether a shift from intravenous to oral antibiotics once the patient is in stable condition would result in efficacy and safety similar to those with continued intravenous treatment is unknown. METHODS: In a randomized, noninferiority, multicenter trial, we assigned 400 adults in stable condition who had endocarditis on the left side of the heart caused by streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci and who were being treated with intravenous antibiotics to continue intravenous treatment (199 patients) or to switch to oral antibiotic treatment (201 patients). In all patients, antibiotic treatment was administered intravenously for at least 10 days. If feasible, patients in the orally treated group were discharged to outpatient treatment. The primary outcome was a composite of all-cause mortality, unplanned cardiac surgery, embolic events, or relapse of bacteremia with the primary pathogen, from the time of randomization until 6 months after antibiotic treatment was completed. RESULTS: After randomization, antibiotic treatment was completed after a median of 19 days (interquartile range, 14 to 25) in the intravenously treated group and 17 days (interquartile range, 14 to 25) in the orally treated group (P=0.48). The primary composite outcome occurred in 24 patients (12.1%) in the intravenously treated group and in 18 (9.0%) in the orally treated group (between-group difference, 3.1 percentage points; 95% confidence interval, -3.4 to 9.6; P=0.40), which met noninferiority criteria. CONCLUSIONS: In patients with endocarditis on the left side of the heart who were in stable condition, changing to oral antibiotic treatment was noninferior to continued intravenous antibiotic treatment. (Funded by the Danish Heart Foundation and others; POET ClinicalTrials.gov number, NCT01375257 .).
Authors: Erin K McCreary; M Hong Nguyen; Matthew R Davis; Jared Borlagdan; Ryan K Shields; Anthony D Anderson; Ryan M Rivosecchi; Rachel V Marini; Lauren M Sacha; Fernanda P Silveira; David R Andes; Alexander J Lepak Journal: J Antimicrob Chemother Date: 2020-10-01 Impact factor: 5.790
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