NCT01875263终止3 期
Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
Fundación Pública Andaluza Progreso y Salud11 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
研究概览
简要总结
Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years with a minimum weight of 40 kg.
- •Microbiological Isolation of S. aureus susceptible to meticillin.
- •Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
- •Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.
- •Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.
排除标准
- •Polymicrobial bacteremia.
- •Neutropenic patients.
- •Patients addicted to intravenous drugs.
- •Patients with malignancies with expected survival less than 6 months.
- •Severe allergy to beta-lactams or fluoroquinolones.
- •Creatinine clearance <20ml/min.
- •Need for hemodialysis, peritoneal dialysis or plasmapheresis.
- •Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
- •Predictors of bacteremia complicated:
- •Positive blood cultures for 48-96 hours of starting treatment antistaphylococcal
- •Clinical Instability
- •Signs of sepsis or persistent fever at day 4 of treatment
- •Existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days
- •Heart disease predisposing to endocarditis.
- •Patients presenting diagnosis concomitant infection by another organism.
- •Pregnant or breast-feeding.
- •Patients with epilepsy.
- •Patients with a history of tendon disorders related to fluoroquinolone administration.
- •Not have signed informed consent.
研究组 & 干预措施
Control
Active Comparator
Cloxacillin 2g / 4 hrs iv 14 days
干预措施: Cloxacillin (Drug)
Experimental
Experimental
Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.
干预措施: Cloxacilin (Drug)
Experimental
Experimental
Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
时间窗: 18 months
次要结局
- Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.(18 months)
- Reduce the transesophagic echocardiography(18 months)
研究者
研究点 (11)
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