Peroral antibiotic treatment of endocarditis

INTERVENTION: Product Name: Antibacterial for systemic use Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion Product Name: Antibacterials for systemic use Pharmaceutical Form: Tablet CONDITION: Bacterial endocarditis caused by streptococci, enterococci, staphylococcus aureus or coagulase‐negative staphylococci Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To examine if oral antibacterial treatment in the last part of the treatment period is equally safe and efficient as intravenous treatment in bacterial endocarditis Primary end point(s): ‐death <6 months after end of treament ; ‐Heart surgery, not planned at randomisation, <6 monts after end of ; treatment ; ‐Emboli after randomisation until <6 months after end of treatment ; ‐Bacteremia with the same bacteria <6 months after end of treatment Secondary Objective: 1. To examine i partly peroral antibiotic tretment and out‐patient treatment has any effect on patients quality of life comparing full‐time intravenous treatment as in‐patient; 2. To examine any economical consequences of partly peroral treatment comparing full‐time intravenous treatment as an in‐patient Timepoint(s) of evaluation of this end point: Consecutively SECONDARY OUTCOME: Secondary end point(s): Quality of life assessed by ; ‐SF36 version2 ; ‐Hospital anxiety and depression scale ; ‐Impact of event scale ; ‐Sate Trait anxiety inventory ; ‐Economical burden of inpatient treatment ; ‐Switch of therapy during treatment due to ; a) Therapeutic failure ; b)allergy ; c) other complication or interaction with other drugs given ; ‐ Duration of antibiotic treatment after randomisation ; ‐Number of cerebral infarctions during therapy assessed by cerebral MRI scan ; ‐Complications of the intravenous catheters Timepoint(s) of evaluation of this end point: For the Quality of life assessement: a)at randomisation b) at end‐of treatment c) after 3 and d) after 6 months ; For the MRI scan: At randomisation and at end of treatment ; For the economic calculation: at 6 month after end of treatment ; For the others: consecutively INCLUSION CRITERIA: Patient admitted to hospital with a diagnosis of left‐sided endocarditis as evaluated by a project responsible physician in one of the study sites: ‐A diagnosis of endocarditis as evaluated by the Duke criteria ‐ Endocarditis with any of the following bacteria: ‐ streptococci ‐staphylococci ‐enterococci ‐Patients >=18 years ‐Patient has received at least 10 days of correct intravenous antibiotic treatment for bacterial endocarditis, or at least 7 days treatment after surgical intervention ‐At least 10 days of the antibiotic therapy is left ‐Temperatur <=37.5 C for 2 days ‐Decline in blood inflammation parameters (serum‐CRP at least 75% comparing peak‐value or<;4 x upper limit of normal, and leucocytes at least 25% of peak‐value or 15 mia/L) during the antibiotic treatment ‐No signs of abscess or any worsening of valve function as assessed by transthoracal or transoesophageal ekkocardiography<;48 hours prior t