Partial oral treatment of endocarditis.
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.


METHODS
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.


CONCLUSIONS
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.
Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. kasper.iversen@dadlnet.dk
Kasper
K
Iversen
Nis
N
Høst
Niels Eske
NE
Bruun
Hanne
H
Elming
Bettina
B
Pump
Jens Jørgen
JJ
Christensen
Sabine
S
Gill
Flemming
F
Rosenvinge
Henrik
H
Wiggers
Kurt
K
Fuursted
Claus
C
Holst-Hansen
Eva
E
Korup
Henrik Carl
HC
Schønheyder
Christian
C
Hassager
Dan
D
Høfsten
Jannik Helweg
JH
Larsen
Claus
C
Moser
Nikolaj
N
Ihlemann
Henning
H
Bundgaard
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004697:Endocarditis, Bacterial / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents