NCT01186172Unknown3 期
Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato
Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ratio of saved devices
研究概览
简要总结
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >1 year and 10 Kgs
- •Long-term vascular device in place at least for 7 days
- •Catheter-related infection (at least presumed)
- •Will to save the infected device (expected high risk access)
排除标准
- •Known ethanol-allergy
- •Known antabuse-like drugs in use
- •Religious refusal
- •S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
- •Tract or pocket infection
- •Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)
研究组 & 干预措施
Ethanol-lock
Experimental
Treatment with a combination of ethanol-lock and parenteral therapy
干预措施: Ethanol-lock therapy (Drug)
Antibiotic lock
Active Comparator
Treatment with a combination of antibiotic-lock and parenteral therapy
干预措施: Antibiotic-lock (Drug)
结局指标
主要结局
Ratio of saved devices
时间窗: 7 days
次要结局
- Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability(60 days)
- Number of patients with proper parenteral therapy(7 days)
- Ratio of saved devices(15-30-60 days)
- Time for next bacteriemic episode(30 days after the end of lock)
研究者
Michele Pagani
Dirigente Medico 1 livello
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (1)
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