跳至主要内容
临床试验/EUCTR2017-003612-39-ES
EUCTR2017-003612-39-ES进行中(未招募)1 期

Randomized clinical trial on the need for antibiotic to treat low-risk catheter bacteremia due to coagulase-negative staphylococci.

Fundació Parc Taulí0 个研究点目标入组 250 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Men and women over 18 years of age
  • 2. Bacteremia due to coagulase-negative staphylococcal related to the venous catheter defined as detection of growth of coagulase-negative staphylococci (excluding S lugdunensis) in patients with a venous catheter, with the presence of clinical symptoms of infection and in the absence of other apparent foci of bacteremia, with the exception of the catheter itself.
  • 3. Patients without risk factors for complications defined as absence of: septic shock, neutropenia (<500 Ne/uL), coagulase-negative staphylococci of the S lugdunensis type, moderate-severe valvular heart disease, artificial endovascular devices other than the catheter and signs of septic thrombophlebitis
  • 4. Patients who have had the catheter removed within 24h prior to inclusion
  • 5. Patients who have signed informed consent to participate in the study
  • 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 125
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 125

排除标准

  • 1. Pregnant and breast-feeding patients
  • 2. Patients who have not had the catheter removed
  • 3. Patients with compromise of immunity
  • 4. Hemodynamically unstable patients
  • 5. Patients with prosthetic materials other than the catheter
  • 6. Patients unable to give their informed consent freely or with inadequate cognitive capacity
  • 7. Any circumstance that, at the discretion of the physician, may involve a risk or clinical detriment to the participation of the patient in the study or that interferes with the assessments of the same.

研究者

发起方
Fundació Parc Taulí

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