Efficacy of Nebulized Versus Intravenous Colimycin for Treating Ventilator-associated Pneumonia Caused by Gram-negative Multidrug-resistant Bacteria: a Prospective, Multicenter, Randomized and Double-blind Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria
研究概览
简要总结
Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.
详细描述
VAP is the most frequent nosocomial infection in critically ill patients and affects length of stay and cost in Intensive Care Unit. The increased incidence of nosocomial infections caused by MDR bacteria becomes a major health problem worldwide.
Nowadays, few antimicrobials are available to treat Gram negative MDR VAP. Colimycin often remains the only active antibiotic. Treating VAP by intravenous (IV) colimycin has two main limitations: risk of renal toxicity and low tissue penetration. Nebulization of colimycin offers the possibility of generating high lung tissue concentrations, rapid bactericidal effects and low systemic accumulation in experimental models. To date however, there is no study comparing clinical effectiveness of nebulized and intravenous colimycin.
We make the hypothesis that nebulized colimycin increases the clinical cure rate of VAP caused by Gram negative MDR bacteria compared to IV colimycin.
Primary Objective: To demonstrate the superiority of nebulized colimycin over intravenous colimycin for treating VAP caused by Gram-negative MDR bacteria.
Secondary Objectives:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group
Patients receive simultaneously nebulized colimycin every 8 h and intravenous placebo administered once, twice or 3 times per day according to renal function
干预措施: Intravenous placebo (Drug)
Experimental group
Patients receive simultaneously nebulized colimycin every 8 h and intravenous placebo administered once, twice or 3 times per day according to renal function
干预措施: Nebulized colimycin (Drug)
Control group
Patients receive simultaneously intravenous colimycin administered once, twice or 3 times per day according to function renal and nebulized placebo every 8 h
干预措施: Intravenous colimycin (Drug)
Control group
Patients receive simultaneously intravenous colimycin administered once, twice or 3 times per day according to function renal and nebulized placebo every 8 h
干预措施: Nebulized placebo (Drug)
结局指标
主要结局
Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria
时间窗: At end of therapy visit (day11) or before day11 if treatment is considered as failed.
Clinical cure is defined as: * resolution of clinical and biological signs of infection and improved radiological signs * and modified clinical pulmonary infection score (CPIS) less than 6 * and negative culture of lower respiratory tract specimen or, successful weaning from invasive mechanical ventilation between day 5 and day 11 * patient colonized with the same pathogen in the respiratory tract is considered as cured, if clinical and biological signs of infection resolved, radiological signs improved, CPIS \< 6 and/or successful weaning from invasive mechanical ventilation has been obtained.
次要结局
- Mortality(day 28 and day 90)
- Microbiological cure rate(At end of therapy visit (day11) or before day11 if treatment is considered as failed.)
- VAP recurrence rate(day 28)
- Duration of mechanical ventilation(Participants will be followed for the duration of ICU stay, an expected average of 3 weeks)
- Renal function during colimycin administration(from Day 1 to Day 11)
- Side effects resulting from colimycin intravenous administration(from Day 1 to day 28)
- Lung superinfection rate(day 11, day 28)
- Length of ICU stay(Participants will be followed for the duration of ICU stay, an expected average of 2 months)
- Side effects resulting from colimycin nebulization(from Day 1 to Day 11)