Endocarditis
Conditions
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.
Interventions
DRUGOral treatment with antibiotics for endocarditis
DRUGGuideline treatment with parenteral antibiotics
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Approximately 7 months. From randomisation until 6 months after end of study medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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 | Approximately 7 months. From randomisation until 6 months after end of study medication | — |
| Duration of antibiotic therapy | Approximately 7 months. From randomisation until 6 months after end of study medication | — |
| Complications related to intravenous catheter | 6 weeks | — |
Countries
Denmark
Outcome results
None listed