A Phase 4 interventional study of Oral treatment with antibiotics for endocarditis and Guideline treatment with parenteral antibiotics in Endocarditis, sponsored by Rigshospitalet, Denmark. Completed at 8 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment
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.
170 studies on the registry are indexed under Endocarditis; 51 are open to participants now.
This study's enrollment of 400 is above the median of 77 across 82 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Infected with one of the following microorganisms:
Exclusion Criteria:
Guideline treatment with parenteral antibiotics
Drug: Guideline treatment with parenteral antibiotics
Oral treatment with antibiotics based on resistens pattern
Drug: Oral treatment with antibiotics for endocarditis
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
Quality of life
QOL performed during the study and after completion of the study
Time frame: Approximately 7 months. From randomisation until 6 months after end of study medication
Cost of treatment
Time frame: Approximately 7 months. From randomisation until 6 months after end of study medication
Duration of antibiotic therapy
Time frame: Approximately 7 months. From randomisation until 6 months after end of study medication
Complications related to intravenous catheter
Time frame: 6 weeks
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark