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Accelerated treatment of endocarditis—The POET II trial : Rationale and design of a randomized controlled trial: Design and rationale of the POET II trial

Østergaard, Lauge ; Pries-Heje, Mia Marie ; Hasselbalch, Rasmus Bo ; Rasmussen, Magnus LU ; Åkesson, Per LU ; Horvath, Robert ; Povlsen, Jonas ; Gill, Sabine ; Bruun, Niels Eske and Müllertz, Katrine , et al. (2020) In American Heart Journal 227. p.40-46
Abstract

Background: The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients. Objective: The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE. Methods: The POET II trial is a multicenter,... (More)

Background: The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients. Objective: The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE. Methods: The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization. Conclusions: The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.

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publishing date
type
Contribution to journal
publication status
published
subject
in
American Heart Journal
volume
227
pages
7 pages
publisher
Mosby-Elsevier
external identifiers
  • scopus:85087633657
  • pmid:32673830
ISSN
0002-8703
DOI
10.1016/j.ahj.2020.05.012
language
English
LU publication?
no
id
2e803088-17a5-479b-9953-2ea67eac8e3d
date added to LUP
2020-07-21 13:34:35
date last changed
2024-05-02 13:23:04
@article{2e803088-17a5-479b-9953-2ea67eac8e3d,
  abstract     = {{<p>Background: The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients. Objective: The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE. Methods: The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization. Conclusions: The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.</p>}},
  author       = {{Østergaard, Lauge and Pries-Heje, Mia Marie and Hasselbalch, Rasmus Bo and Rasmussen, Magnus and Åkesson, Per and Horvath, Robert and Povlsen, Jonas and Gill, Sabine and Bruun, Niels Eske and Müllertz, Katrine and Tuxen, Christian Ditlev and Ihlemann, Nikolaj and Helweg-Larsen, Jannik and Moser, Claus and Fosbøl, Emil Loldrup and Bundgaard, Henning and Iversen, Kasper}},
  issn         = {{0002-8703}},
  language     = {{eng}},
  pages        = {{40--46}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{American Heart Journal}},
  title        = {{Accelerated treatment of endocarditis—The POET II trial : Rationale and design of a randomized controlled trial: Design and rationale of the POET II trial}},
  url          = {{http://dx.doi.org/10.1016/j.ahj.2020.05.012}},
  doi          = {{10.1016/j.ahj.2020.05.012}},
  volume       = {{227}},
  year         = {{2020}},
}