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

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Lauge Østergaard, Rigshospitalet
  • ,
  • Mia Marie Pries-Heje, Rigshospitalet
  • ,
  • Rasmus Bo Hasselbalch, Herlev-Gentofte Hospital
  • ,
  • Magnus Rasmussen, Skåne University Hospital, Lund
  • ,
  • Per Åkesson, Skåne University Hospital, Lund
  • ,
  • Robert Horvath, The Prince Charles Hospital
  • ,
  • Jonas Povlsen
  • Sabine Gill, Odense University Hospital
  • ,
  • Niels Eske Bruun, Københavns Universitet
  • ,
  • Katrine Müllertz, Nordsjaellands Hospital
  • ,
  • Christian Ditlev Tuxen, Bispebjerg and Frederiksberg Hospital
  • ,
  • Nikolaj Ihlemann, Rigshospitalet
  • ,
  • Jannik Helweg-Larsen, Rigshospitalet
  • ,
  • Claus Moser, Rigshospitalet
  • ,
  • Emil Loldrup Fosbøl, Rigshospitalet
  • ,
  • Henning Bundgaard, Rigshospitalet
  • ,
  • Kasper Iversen, Herlev-Gentofte Hospital

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.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind227
Sider (fra-til)40-46
Antal sider7
ISSN0002-8703
DOI
StatusUdgivet - sep. 2020

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