Partial oral treatment of endocarditis

Kasper Iversen; Nis Høst; Niels Eske Bruun; Hanne Elming; Bettina Pump; Jens Jørgen Christensen; Sabine Gill; Flemming Schønning Rosenvinge; Henrik Wiggers; Kurt Fuursted; Claus Holst-Hansen; Eva Korup; Henrik Carl Schønheyder; Christian Hassager; Dan Eik Høfsten; Jannik Helweg-Larsen; Claus Moser; Nikolaj Ihlemann; Henning Bundgaard

doi:10.1016/j.ahj.2012.11.006

Partial oral treatment of endocarditis

Kasper Iversen, Nis Høst, Niels Eske Bruun, Hanne Elming, Bettina Pump, Jens Jørgen Christensen, Sabine Gill, Flemming Schønning Rosenvinge, Henrik Wiggers, Kurt Fuursted, Claus Holst-Hansen, Eva Korup, Henrik Carl Schønheyder, Christian Hassager, Dan Eik Høfsten, Jannik Helweg-Larsen, Claus Moser, Nikolaj Ihlemann, Henning Bundgaard

22 Citations (Scopus)

Abstract

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.

Original language	English
Journal	American Heart Journal
Volume	165
Issue number	2
Pages (from-to)	116-22
Number of pages	7
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2012.11.006
Publication status	Published - Feb 2013

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Iversen, K., Høst, N., Bruun, N. E., Elming, H., Pump, B., Christensen, J. J., Gill, S., Rosenvinge, F. S., Wiggers, H., Fuursted, K., Holst-Hansen, C., Korup, E., Schønheyder, H. C., Hassager, C., Høfsten, D. E., Helweg-Larsen, J., Moser, C., Ihlemann, N., & Bundgaard, H. (2013). Partial oral treatment of endocarditis. American Heart Journal, 165(2), 116-22. https://doi.org/10.1016/j.ahj.2012.11.006

Iversen, K, Høst, N, Bruun, NE, Elming, H, Pump, B, Christensen, JJ, Gill, S, Rosenvinge, FS, Wiggers, H, Fuursted, K, Holst-Hansen, C, Korup, E, Schønheyder, HC, Hassager, C, Høfsten, DE, Helweg-Larsen, J, Moser, C, Ihlemann, N & Bundgaard, H 2013, 'Partial oral treatment of endocarditis', American Heart Journal, vol. 165, no. 2, pp. 116-22. https://doi.org/10.1016/j.ahj.2012.11.006

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abstract = "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.",

author = "Kasper Iversen and Nis H{\o}st and Bruun, {Niels Eske} and Hanne Elming and Bettina Pump and Christensen, {Jens J{\o}rgen} and Sabine Gill and Rosenvinge, {Flemming Sch{\o}nning} and Henrik Wiggers and Kurt Fuursted and Claus Holst-Hansen and Eva Korup and Sch{\o}nheyder, {Henrik Carl} and Christian Hassager and H{\o}fsten, {Dan Eik} and Jannik Helweg-Larsen and Claus Moser and Nikolaj Ihlemann and Henning Bundgaard",

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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 Schønning

AU - Wiggers, Henrik

AU - Fuursted, Kurt

AU - Holst-Hansen, Claus

AU - Korup, Eva

AU - Schønheyder, Henrik Carl

AU - Hassager, Christian

AU - Høfsten, Dan Eik

AU - Helweg-Larsen, Jannik

AU - Moser, Claus

AU - Ihlemann, Nikolaj

AU - Bundgaard, Henning

PY - 2013/2

Y1 - 2013/2

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.

U2 - 10.1016/j.ahj.2012.11.006

DO - 10.1016/j.ahj.2012.11.006

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C2 - 23351813

SN - 0002-8703

VL - 165

SP - 116

EP - 122

JO - American Heart Journal

JF - American Heart Journal

IS - 2

ER -

Partial oral treatment of endocarditis

Abstract

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