NCT01375257

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6.2 years

First QC Date

June 13, 2011

Last Update Submit

March 9, 2019

Conditions

Endocarditis

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen

    Approximately 7 months. From randomisation until 6 months after end of study medication

Secondary Outcomes (4)

  • Quality of life

    Approximately 7 months. From randomisation until 6 months after end of study medication

  • Cost of treatment

    Approximately 7 months. From randomisation until 6 months after end of study medication

  • Duration of antibiotic therapy

    Approximately 7 months. From randomisation until 6 months after end of study medication

  • Complications related to intravenous catheter

    6 weeks

Study Arms (2)

Guideline treatment with parenteral antibiotics

ACTIVE COMPARATOR

Guideline treatment with parenteral antibiotics

Drug: Guideline treatment with parenteral antibiotics

Oral treatment with antibiotics

EXPERIMENTAL

Oral treatment with antibiotics based on resistens pattern

Drug: Oral treatment with antibiotics for endocarditis

Interventions

Oral treatment with antibiotics for endocarditisDRUG
Oral treatment with antibiotics
Guideline treatment with parenteral antibioticsDRUG
Guideline treatment with parenteral antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aalborg Sygehus

Aalborg, Denmark

Location

Skejby Sygehus

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Gentofte Hospital

Copenhagen, Denmark

Location

Herlev Hoslpital

Copenhagen, Denmark

Location

Hillerød Hospital

Hillerød, Denmark

Location

Odense Sygehus

Odense, 5000, Denmark

Location

Roskilde Sygehus

Roskilde, Denmark

Location

Related Publications (3)

  • Bundgaard JS, Iversen K, Pries-Heje M, Ihlemann N, Gill SU, Madsen T, Elming H, Povlsen JA, Bruun NE, Hofsten DE, Fuursted K, Christensen JJ, Schultz M, Rosenvinge F, Helweg-Larsen J, Kober L, Torp-Pedersen C, Fosbol EL, Tonder N, Moser C, Bundgaard H, Mogensen UM. Self-assessed health status and associated mortality in endocarditis: secondary findings from the POET trial. Qual Life Res. 2022 Sep;31(9):2655-2662. doi: 10.1007/s11136-022-03126-x. Epub 2022 Mar 29.

    PMID: 35349038DERIVED

  • Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28.

    PMID: 30152252DERIVED

  • Iversen K, Host N, Bruun NE, Elming H, Pump B, Christensen JJ, Gill S, Rosenvinge F, Wiggers H, Fuursted K, Holst-Hansen C, Korup E, Schonheyder HC, Hassager C, Hofsten D, Larsen JH, Moser C, Ihlemann N, Bundgaard H. Partial oral treatment of endocarditis. Am Heart J. 2013 Feb;165(2):116-22. doi: 10.1016/j.ahj.2012.11.006. Epub 2013 Jan 3.

    PMID: 23351813DERIVED

MeSH Terms

Conditions

Endocarditis

Interventions

TherapeuticsAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 17, 2011

Study Start

July 1, 2011

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

DK(8)