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
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