To compare the efficacy of two combination therapies against carbapenem resistant enterobacteriaceaeMeropenem plus colistin versus high dose tigecycline plus colistin in critically ill patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To see the changes in sequential organ failure assessment (SOFA) score at zero hour and after 48 hours of starting combination therapies meropenem plus colistin and high dose tigecycline plus colistin in carbapenem resistant enterobacteriaceae positive cases.
研究概览
简要总结
Carbepenem resistant enterobacteriaceae (CRE) , a major resistance concern during last decade and become the important focus of infection .
New and effective therapeutic strategies developed for the treatment of CRE positive patients like to increasing the doses of anti CRE agents and to combine these anti CRE infections .
AIM OF THE STUDY :
PRIMARY OBJECTIVE : see the SOFA score changes at zero hour and 48hours of starting the treatments
SECONDARY OBJECTIVE: See the microbiological eradication and mortality within 5th day starting the antibiotics.
METHODS AAND MATERIALS: Study will be conducted on 80 patients admitted in the icu/ccw of JNMCH,AMU,ALIGARH
Group A will receive meropenem(1gm 3 times daily ) and colistin (9MIU loadind followed by 2-3 MIU) while group B receive high dose tigecycline (200mg loadind followed by 100mg 2 times a day) and colistin
RESULT: To see changes in SOFA SCORE AFTER 48 HOURS OF STARTING THE ANTIBIOTICS COMBINATION AND SEE THE ERADICATION AND MORTALITY WITHIN 5TH DAY .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient having sepsis and SOFA score of 2 or more than 2 at the time of admission in icu/ccw.
- •2.There should be an isolates of carbapenem resistant enterobacteriaceae (CRE) positive either from Blood, tracheal aspirates, urine or abdominal pus culture.
- •3.Patient on any empirical antibiotics except current combination therapy .
排除标准
- •1.Patient who is not having sepsis and having SOFA score of less than
- •Non Carbapenem resistant enterobacteriaceae (CRE) patients.
- •3.Patient who expire within 48 hours of starting the combination therapy.
- •4.Patient having sensitivity to the drug use .
- •5.Covid -19 positive patients.
结局指标
主要结局
To see the changes in sequential organ failure assessment (SOFA) score at zero hour and after 48 hours of starting combination therapies meropenem plus colistin and high dose tigecycline plus colistin in carbapenem resistant enterobacteriaceae positive cases.
时间窗: 2 days
次要结局
- To see the microbiological eradication of carbapenem resistant enterobacteriaceae on 5th day and to report any mortality within 5 days of starting the antibiotics combination therapies .(5 days)