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American heart journal · Feb 2013
Randomized Controlled Trial Multicenter Study Comparative StudyPartial oral treatment of endocarditis.
- Kasper Iversen, Nis Høst, Niels Eske Bruun, Hanne Elming, Bettina Pump, Jens Jørgen Christensen, Sabine Gill, Flemming Rosenvinge, Henrik Wiggers, Kurt Fuursted, Claus Holst-Hansen, Eva Korup, Henrik Carl Schønheyder, Christian Hassager, Dan Høfsten, Jannik Helweg Larsen, Claus Moser, Nikolaj Ihlemann, and Henning Bundgaard.
- Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. kasper.iversen@dadlnet.dk
- Am. Heart J. 2013 Feb 1; 165 (2): 116-22.
BackgroundGuidelines for the treatment of left-sided infective endocarditis (IE) recommend 4 to 6 weeks of intravenous antibiotics. Conversion from intravenous to oral antibiotics in clinically stabilized patients could reduce the side effects associated with intravenous treatment and shorten the length of hospital stay. Evidence supporting partial oral therapy as an alternative to the routinely recommended continued parenteral therapy is scarce, although observational data suggest that this strategy may be safe and effective.Study DesignThis is a noninferiority, multicenter, prospective, randomized, open-label study of partial oral treatment with antibiotics compared with full parenteral treatment in left-sided IE. Stable patients (n = 400) with streptococci, staphylococci, or enterococci infecting the mitral valve or the aortic valve will be included. After a minimum of 10 days of parenteral treatment, stable patients are randomized to oral therapy or unchanged parenteral therapy. Recommendations for oral treatment have been developed based on minimum inhibitory concentrations and pharmacokinetic calculations. Patients will be followed up for 6 months after completion of antibiotic therapy. The primary end point is a composition of all-cause mortality, unplanned cardiac surgery, embolic events, and relapse of positive blood cultures with the primary pathogen.ConclusionThe Partial Oral Treatment of Endocarditis study tests the hypothesis that partial oral antibiotic treatment is as efficient and safe as parenteral therapy in left-sided IE. The trial is justified by a review of the literature, by pharmacokinetic calculations, and by our own experience.Copyright © 2013 Mosby, Inc. All rights reserved.
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