Partial Oral Treatment of Endocarditis (POET)
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ClinicalTrials.gov Identifier: NCT01375257 |
Recruitment Status :
Completed
First Posted : June 17, 2011
Last Update Posted : March 12, 2019
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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 or disease | Intervention/treatment | Phase |
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Endocarditis | Drug: Oral treatment with antibiotics for endocarditis Drug: Guideline treatment with parenteral antibiotics | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Partial Oral Treatment of Endocarditis |
Actual Study Start Date : | July 2011 |
Actual Primary Completion Date : | August 30, 2017 |
Actual Study Completion Date : | August 30, 2017 |

Arm | Intervention/treatment |
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Active Comparator: Guideline treatment with parenteral antibiotics
Guideline treatment with parenteral antibiotics
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Drug: Guideline treatment with parenteral antibiotics |
Experimental: Oral treatment with antibiotics
Oral treatment with antibiotics based on resistens pattern
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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 [ 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: Approximately 7 months. From randomisation until 6 months after end of study medication ]
- Complications related to intravenous catheter [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Left-sided endocarditis based on the Duke criteria
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375257
Denmark | |
Aalborg Sygehus | |
Aalborg, Denmark | |
Skejby Sygehus | |
Aarhus, Denmark, 8200 | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Gentofte Hospital | |
Copenhagen, Denmark | |
Herlev Hoslpital | |
Copenhagen, Denmark | |
Hillerød Hospital | |
Hillerød, Denmark | |
Odense Sygehus | |
Odense, Denmark, 5000 | |
Roskilde Sygehus | |
Roskilde, Denmark |
Responsible Party: | Kasper Iversen, Consultant, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT01375257 |
Other Study ID Numbers: |
Endocarditis-DK |
First Posted: | June 17, 2011 Key Record Dates |
Last Update Posted: | March 12, 2019 |
Last Verified: | March 2019 |
Endocarditis Heart Diseases Cardiovascular Diseases Anti-Bacterial Agents |
Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |