NCT00610623终止2 期
Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
Anbics Management-Services Ag19 个研究点 分布在 6 个国家目标入组 92 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 92
- 试验地点
- 19
- 主要终点
- Occurrence of and time to Pseudomonas aeruginosa pneumonia
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non pregnant female aged 18 to 75 years
- •Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
- •Reasonable survival chance within next few days with an Apache score 10-25
- •Tracheal aspirate found positive for P. aeruginosa
- •The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
- •Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member
排除标准
- •Poor prognosis as judged by Apache score II score >25
- •Pregnant female
- •Grossly under-or overweight (BMI<18or >29)
- •Ongoing therapy with a macrolide
- •Known allergy to any macrolide
- •Proven P. aeruginosa pneumonia
- •Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
- •Anticipated short duration of mechanical ventilation (<3 days)
- •Known drug interaction that could either decrease efficacy or raise safety concerns
- •Severe hepatic failure (type C, score >10 on Child Pugh scale)
- •Sick sinus syndrome or long QT syndrome
- •Recent donation of blood or participation in another clinical trial within 3 months
- •Any situation exposing the patient to higher risk or possibly confounding results
研究组 & 干预措施
1
Experimental
azithromycin iv 300 mg/day
干预措施: azithromycin (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Occurrence of and time to Pseudomonas aeruginosa pneumonia
时间窗: daily
次要结局
- occurrence of and time to death(daily)
- time to extubation(daily)
- overall outcome(daily)
- duration of hospitalization and ICU stay(daily)
- occurrence of infections to other bacterial strains(daily)
- cost assessment(daily)
- demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa(daily)
- determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics(daily)
- determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin(daily)
研究者
研究点 (19)
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