Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Therapy of Carbapenem-Resistant Acinetobacter Baumannii Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. The addition of minocycline to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been limited to case report or case series in comparison with colistin alone.
详细描述
The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone.
The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm).
Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.
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)
盲法说明
Double blind, Placebo Controlled
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and microbiological evidence of a severe infection due to multi-drug resistant A. baumannii during hospitalization
- •Susceptibility of the A. baumannii isolate to colistin (MIC < or =2 mg/l).
排除标准
- •Treatment with one of the study drugs prior to the diagnosis of A. baumannii infection more than 48 hours
- •Severe liver dysfunction
- •History of prior hypersensitivity to the study drugs
- •Pregnancy and lactation
研究组 & 干预措施
Colistin plus Placebo
Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo
干预措施: Colistin (Drug)
Colistin plus Placebo
Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo
干预措施: Placebo (Drug)
Colistin plus Minocycline
Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally
干预措施: Colistin (Drug)
Colistin plus Minocycline
Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally
干预措施: Minocycline (Drug)
结局指标
主要结局
All cause mortality
时间窗: 28 days
The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.
次要结局
- Incidence of Renal toxicity (safety)(28 days)
- Incidence of Hepatic toxicity (safety)(28 days)
- Microbiological eradication(28 days)