Clinical Trial: Partial Oral Treatment of Endocarditis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Partial Oral Treatment of Endocarditis

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.


Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: June 13, 2011
Date Started: June 2011
Date Completion:
Last Updated: June 16, 2011
Last Verified: June 2011