Partial oral versus intravenous antibiotic treatment of endocarditis

Kasper Iversen, Nikolaj Ihlemann, Sabine U Gill, Trine Madsen, Hanne Elming, Kaare T Jensen, Niels E Bruun, Dan E Høfsten, Kurt Fursted, Jens J Christensen, Martin Schultz, Christine F Klein, Emil L Fosbøll, Flemming Rosenvinge, Henrik C Schønheyder, Lars Køber, Christian Torp-Pedersen, Jannik Helweg-Larsen, Niels Tønder, Claus MoserHenning Bundgaard

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449 Citations (Scopus)

Abstract

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 .).

Original languageEnglish
JournalThe New England Journal of Medicine
Volume380
Issue number5
Pages (from-to)415-424
Number of pages10
ISSN0028-4793
DOIs
Publication statusPublished - 31 Jan 2019

Keywords

  • Administration, Intravenous
  • Administration, Oral
  • Aged
  • Anti-Bacterial Agents/administration & dosage
  • Bacteremia/drug therapy
  • Endocarditis, Bacterial/drug therapy
  • Female
  • Heart Valve Prosthesis/microbiology
  • Humans
  • Intention to Treat Analysis
  • Kaplan-Meier Estimate
  • Length of Stay
  • Male
  • Middle Aged
  • Recurrence

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