Multicenter Open-label RCT to Compare Colistin Alone vs. Colistin Plus Meropenem
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 7
- 主要终点
- Clinical success
研究概览
简要总结
The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inpatients
- •Clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria and identified according to CDC criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections
- •Patient recruitment will occur only after microbiological documentation and susceptibility testing. Patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period.
排除标准
- •Previous inclusion in the trial. Patients will be included in the RCT only once for the first identified episode of infection
- •Pregnant women
- •Epilepsy or prior seizures
- •Known allergy to colistin or a carbapenem
研究组 & 干预措施
Colistin and Meropenem
IV meropenem, 2 gram q8h, adjusted for renal function IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function
干预措施: Colistin (Drug)
Colistin and Meropenem
IV meropenem, 2 gram q8h, adjusted for renal function IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function
干预措施: Meropenem (Drug)
Colistin
IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function
干预措施: Colistin (Drug)
结局指标
主要结局
Clinical success
时间窗: 14 days
defined as a composite of all of the following, all measured at 14 days: * Patient alive * Systolic blood pressure \>90 mmHg without need for vasopressor support * Stable or improved SOFA score, define as: * for baseline SOFA ≥ 3: a decrease of at least 30%; * for baseline SOFA \<3: stable or decreased SOFA score * For patients with HAP/ VAP, PaO2/FiO2 ratio stable or improved * For patients with bacteremia, no growth of the initial isolate in blood cultures taken on day 14 if patient still febrile
次要结局
- Time to defervescence(28 days)
- CDAD(28 days)
- Time to weaning(28 days)
- Microbiological failure(28 days)
- New resistant infection(28 days)
- Secondary outcomes and adverse events(14 and 28 days)
- Clinical success with modification(14 days)
- Time to hospital discharge(28 days)
- Superinfections(28 days)
研究者
Mical Paul
MD
Rabin Medical Center