Peroral antibiotic treatment of heart valve infectio

Conditions: Bacterial endocarditis caused by streptococci, enterococci, staphylococcus aureus or coagulase-negative staphylococci
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2013-000469-35-NO

Lead Sponsor: Hillerød Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 400

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 to randomisation
-Patients that beside the above mentioned also fulfill the modified OPAT (out-patient antibiotic therapy) criteria may be included in the part of the study concerning ambulatory therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 <br>-Heart surgery, not planned at randomisation, <6 monts after end of <br>treatment <br>-Emboli after randomisation until <6 months after end of treatment <br>-Bacteremia with the same bacteria <6 months after end of treatment;Timepoint(s) of evaluation of this end point: Consecutively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life assessed by <br> -SF36 version2 <br> -Hospital anxiety and depression scale <br> -Impact of event scale <br> -Sate Trait anxiety inventory <br>-Economical burden of inpatient treatment <br>-Switch of therapy during treatment due to <br> a) Therapeutic failure <br> b)allergy <br> c) other complication or interaction with other drugs given <br>- Duration of antibiotic treatment after randomisation <br>-Number of cerebral infarctions during therapy assessed by cerebral MRI scan <br>-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 <br>For the MRI scan: At randomisation and at end of treatment <br>For the economic calculation: at 6 month after end of treatment <br>For the others: consecutively