Peroral antibiotic treatment of endocarditis - POET

Hillerød Hospital0 个研究点目标入组 400 人开始时间: 2013年5月15日最近更新: 2013年12月9日

适应症

试验速览

暂无简介。

•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

•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
•-Any abdominal/ bowel disease that may reduce uptake of oral
•- 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

发起方

Hillerød Hospital