跳至主要内容
临床试验/NCT05791357
NCT05791357已完成不适用

The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis: Modern Diagnostic and Therapeutic Concepts

Fondazione Policlinico Universitario Agostino Gemelli IRCCS4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
4
主要终点
number of microorganism isolated

研究概览

简要总结

The aim of this study is to prospectively investigate the additional diagnostic value of broad range PCR targeting the 16 ribosomal DNA in diagnosis and management of patients with infective endocarditis who are candidate for surgicaltherapy;

详细描述

Study protocol is divided into four different phases:screening, pre-operative clinical assessment (T-1), cardiac surgery (T0) and follow-up period (T4 eT90).

During the screening phase, patients will be assessed to determine whether they met the study inclusion/exclusion criteria. After signing the informed consent, patients will go through a preoperative clinical evaluation (T-1). The following assessments are carried out the day before surgery: recording patient's generality, present antibiotic therapy and possible results of blood cultures performed prior to recruitment; - Twelve-lead ECG; - chest X-ray - transthoracic echocardiogram (TTE); -. three pairs of blood cultures from three different blood sampling sites. In cases of complicated endocarditis, the presence and location of septic embolisms is recorded (using Total body CT scan imaging), signs of heart failure evaluated and operability criteria are assessed. On the day of cardiac surgery (T0), main intraoperative data (valve findings, type of prosthesis, surgery time, cardiopulmonary bypass time and aortic cross clamping time) will be gathered; the excised valve was sent partly to the microbiology laboratory for culture and molecular tests and partly to the pathology Laboratory.

After cardiac surgery, patients continued to be monitored for a follow up at four (T4) and 90 (T90) days after surgery. During the follow-up period, information was collected on the patient's clinical status (vital parameters) and the antibiotic treatment performed. The same blood tests performed at T-1 are repeated at T4 and T90. All this data was recorded on a dedicated database.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 18 years, with diagnosis of IE on a native or prosthetic valve and with a surgical indication for heart valve replacement using extracorporeal circulation (CPB).
  • patients who have signed informed consent to the partecipation of the study
  • Exclusion criteria:
  • patients younger than 18 years
  • Failure to sign consent for personal data processing and/or study participation
  • Participation in other experimental studies
  • Patients who did not complete the examinations under study (culture test on blood and excised valve, molecular tests)

排除标准

  • 未提供

结局指标

主要结局

number of microorganism isolated

时间窗: through study completion, an average of 1 year

number of microorganism isolated through molecular diagnostic tests

Impact of molecular diagnostic tests on the identification of microorganisms

时间窗: through study completion, an average of 1 year

number of patients with positive blood cultures vs number of patients with negative blood cultures but with positive molecular diagnostic tests

次要结局

  • Impact of molecular diagnostic tests on antibiotic therapy(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验