Bacterial endocarditis caused by streptococci, enterococci, staphylococcus aureus or coagulase-negative staphylococci
Conditions
Interventions
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:
Sponsors
Hillerød Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Previous endocarditis within the last year with the same bacteria (endocarditis-relapse) -Body mass index >40 kg/m2 -Heart surgery planned within 6 weeks from randomisation -Any other concurrent infection that needs intravenous antibiotic therapy -Any abdominal/ bowel disease that may reduce uptake of oral medication - Known reduced immunocompetence such as HIV, or treatment with chemotherapeutics or prednisolon >20mg/day -Subjects incapable of giving informed consent -Subjects with low complience included inravenous drug users
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 ;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;Timepoint(s) of evaluation of this end point: Consecutively | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Norway
Contacts
Public ContactKasper Iversen
Rigshospitalet
Outcome results
None listed