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Partial Oral Treatment of Endocarditis (POET)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: June 13, 2011
Last updated: June 16, 2011
Last verified: June 2011

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.

Condition Intervention Phase
Drug: Oral treatment with antibiotics for endocarditis
Drug: Guideline treatment with parenteral antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Oral Treatment of Endocarditis

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
    QOL performed during the study and after completion of the study

  • Cost of treatment [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
  • Duration of antibiotic therapy [ Time Frame: 4 weeks ]
  • Number of cerebral infarcts [ Time Frame: Approximately 7 months. From randomisation until 6 months after end of study medication ]
  • Complications related to intravenous catheter [ Time Frame: 4 weeks ]

Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guideline treatment with parenteral antibiotics Drug: Guideline treatment with parenteral antibiotics
Experimental: Oral treatment with antibiotics Drug: Oral treatment with antibiotics for endocarditis


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01375257

Contact: Kasper Iversen, MD 0045 35459863

Aalborg Sygehus Not yet recruiting
Aalborg, Denmark
Contact: Eva Korup   
Skejby Sygehus Not yet recruiting
Aarhus, Denmark, 8200
Contact: Henrik Wiggers, MD   
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Iversen         
Gentofte Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Niels Bruun, MD   
Odense Sygehus Not yet recruiting
Odense, Denmark, 5000
Contact: Sabine Gill, MD   
Roskilde Sygehus Not yet recruiting
Roskilde, Denmark
Contact: Hanne Elming   
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01375257     History of Changes
Other Study ID Numbers: Endocarditis-DK
Study First Received: June 13, 2011
Last Updated: June 16, 2011

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 25, 2017