TY - JOUR
T1 - Partial oral treatment of endocarditis
AU - Iversen, Kasper
AU - Høst, Nis
AU - Bruun, Niels Eske
AU - Elming, Hanne
AU - Pump, Bettina
AU - Christensen, Jens Jørgen
AU - Gill, Sabine
AU - Rosenvinge, Flemming
AU - Wiggers, Henrik
AU - Fuursted, Kurt
AU - Holst-Hansen, Claus
AU - Korup, Eva
AU - Schønheyder, Henrik Carl
AU - Hassager, Christian
AU - Høfsten, Dan
AU - Larsen, Jannik Helweg
AU - Moser, Claus
AU - Ihlemann, Nikolaj
AU - Bundgaard, Henning
PY - 2013/2/1
Y1 - 2013/2/1
N2 - Background Guidelines 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 Design This 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. Conclusion The 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.
AB - Background Guidelines 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 Design This 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. Conclusion The 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.
UR - http://www.scopus.com/inward/record.url?scp=84872862428&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2012.11.006
DO - 10.1016/j.ahj.2012.11.006
M3 - Article
C2 - 23351813
AN - SCOPUS:84872862428
SN - 0002-8703
VL - 165
SP - 116
EP - 122
JO - American Heart Journal
JF - American Heart Journal
IS - 2
ER -