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

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

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, 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.

Detaljer

Författare
  • Lauge Østergaard
  • Mia Marie Pries-Heje
  • Rasmus Bo Hasselbalch
  • Magnus Rasmussen
  • Per Åkesson
  • Robert Horvath
  • Jonas Povlsen
  • Sabine Gill
  • Niels Eske Bruun
  • Katrine Müllertz
  • Christian Ditlev Tuxen
  • Nikolaj Ihlemann
  • Jannik Helweg-Larsen
  • Claus Moser
  • Emil Loldrup Fosbøl
  • Henning Bundgaard
  • Kasper Iversen
Externa organisationer
  • Copenhagen University Hospital
  • Gentofte Hospital
  • Skåne University Hospital
  • The Prince Charles Hospital
  • Aarhus University Hospital
  • Odense University Hospital
  • Hillerod Hospital
  • Frederiksberg Hospital
  • Zealand University Hospital
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Kardiologi
  • Infektionsmedicin
Originalspråkengelska
Sidor (från-till)40-46
Antal sidor7
TidskriftAmerican Heart Journal
Volym227
StatusPublished - 2020
PublikationskategoriForskning
Peer review utfördJa
Externt publiceradJa