Completed

POETPartial Oral Treatment of Endocarditis

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What is being tested

Oral treatment with antibiotics for endocarditis

+ Guideline treatment with parenteral antibiotics

Drug
Who is being recruted

Cardiovascular Diseases

+ Endocarditis

+ Heart Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorRigshospitalet, Denmark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

Background Current management of infective endocarditis include admission and treatment with parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of present management strategy make it highly relevant to seek for alternative more lenient alternatives. Experiences with oral treatment are only sporadically described, but observational data suggest that oral treatment could be a feasible option. The investigators have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100% success rate. Study design The POET study is a Danish multicenter, prospective, randomized, open label study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics of endocarditis compared to full parenteral treatment. 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, patients will be randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment have been developed based on expected minimal inhibitory concentrations and pharmacokinetic calculations. Patients will be followed for 6 months after completion of antibiotic therapy. The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen.

Official TitlePartial Oral Treatment of Endocarditis
NCT01375257
Principal SponsorRigshospitalet, Denmark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesEndocarditisHeart Diseases

Criteria

Inclusion Criteria: * Left-sided endocarditis based on the Duke criteria * Infected with one of the following microorganisms: * Streptococci * Enterococcus faecalis * Staphylococcus aureus * Coagulase-negative staphylococci. * ≥ 18 years * At least 10 days of appropriate parenteral antibiotic treatment overall, and at least 1 week of appropriate parenteral treatment after valve surgery * Afebrile (T \< 38.0) \> 2 days * Decreasing infection parameters (CRP dropped to less than 25% of peak value or \< 20 mg/l, and white blood cell count \< 15 x 109/l) during antibiotic treatment * No sign of abscess formation by echocardiography * Transthoracic and transoesophageal echocardiography performed within 48 hours prior to randomization Exclusion Criteria: * Body mass index \> 40 * Concomitant infection requiring intravenous antibiotic therapy * Inability to give informed consent to participation * Suspicion of reduced absorption of oral treatment due to abdominal disorder * Reduced compliance

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Oral treatment with antibiotics based on resistens pattern

Group II

Active Comparator
Guideline treatment with parenteral antibiotics

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Herlev Hoslpital

Copenhagen, DenmarkOpen Herlev Hoslpital in Google Maps
Suspended

Hillerød Hospital

Hillerød, Denmark
Suspended

Aalborg Sygehus

Aalborg, Denmark
Suspended

Skejby Sygehus

Aarhus, Denmark
Completed8 Study Centers