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Completed

NCT Number: NCT01375257

Partial Oral Treatment of Endocarditis

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.

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Key information

Conditions

Endocarditis Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg Sygehus, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral treatment with antibiotics for endocarditis

Drug

Guideline treatment with parenteral antibiotics

Drug

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

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

Secondary outcomes

  1. 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

  2. Cost of treatment

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

  3. Duration of antibiotic therapy

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

  4. Complications related to intravenous catheter

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: POET

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2011
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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