TY - JOUR

T1 - Accelerated treatment of endocarditis-The POET II trial

T2 - Rationale and design of a randomized controlled trial

AU - Østergaard, Lauge

AU - Pries-Heje, Mia Marie

AU - Hasselbalch, Rasmus Bo

AU - Rasmussen, Magnus

AU - Åkesson, Per

AU - Horvath, Robert

AU - Povlsen, Jonas

AU - Gill, Sabine

AU - Bruun, Niels Eske

AU - Müllertz, Katrine

AU - Tuxen, Christian Ditlev

AU - Ihlemann, Nikolaj

AU - Helweg-Larsen, Jannik

AU - Moser, Claus

AU - Fosbøl, Emil Loldrup

AU - Bundgaard, Henning

AU - Iversen, Kasper

N1 - Copyright © 2020 Elsevier Inc. All rights reserved.

PY - 2020/9

Y1 - 2020/9

N2 - 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.

AB - 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.

KW - Anti-Bacterial Agents/administration & dosage

KW - Endocarditis, Bacterial/drug therapy

KW - Enterococcus faecalis

KW - Equivalence Trials as Topic

KW - Gram-Positive Bacterial Infections/drug therapy

KW - Humans

KW - Multicenter Studies as Topic

KW - Randomized Controlled Trials as Topic/methods

KW - Staphylococcal Infections/drug therapy

KW - Staphylococcus aureus

KW - Streptococcal Infections/drug therapy

KW - Time Factors

U2 - 10.1016/j.ahj.2020.05.012

DO - 10.1016/j.ahj.2020.05.012

M3 - Journal article

C2 - 32673830

VL - 227

SP - 40

EP - 46

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -