EUCTR2010-021413-23-GR进行中(未招募)不适用
Optimizing Dosing of Colistin for Infections Resistant to all Other Antibiotics
niversity of Athens, Medical School0 个研究点目标入组 238 人开始时间: 2010年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 238
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.Patient of 18 years of age or older
- •2.Expectation of hospitalization of = 48 hours
- •3.Receipt of intravenous colistin for clinical care
- •4.Provision of written informed consent by the patient or by a relative legally able to give proxy consent if the patient cannot give consent
- •5.Infection is defined by Center for Disease Control and Prevention (CDC) definitions of bloodstream infection (bacteremia) or hospital-acquired pneumonia:85
- •6.Patient must have growth from blood culture or a respiratory specimen culture of a Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin
- •7.Adequate venous access to enable collection of blood for determination of CMS and generated colistin in plasma
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Currently pregnant or breastfeeding
- •2.Currently incarcerated
- •3.Concomitant use of colistin or polymyxin B delivered directly into the respiratory tract
- •4.Known allergy to colistin or polymyxin B
- •5.Cystic fibrosis
- •6.Estimated life expectancy of less than one week
研究者
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