Comparison of treatment failure with Minocycline versus Colistin Based Triple Antimicrobial Therapy for Carbapenem Resistant Acinetobacter Baumannii Infection in Critical Care Unit A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of treatment failure after anti-CRAB treatment between minocycline versus colistin based triple antimicrobial therapy for carbapenem resistant Acinetobacter Baumannii Infection in critical care unit for a duration specified by protocol
研究概览
简要总结
Carbapenem resistant A. baumanni(CRAB) was ranked number one priority for antibiotic research and development by WHO. Rise in carbapenem resistance is leading to increased usage of colistin, which eventually increases colistin resistance. Current guidelines recommend combined antimicrobial therapy for moderate to severe CRAB infection in ICU with high dose sulbactam being a component of combination therapy even if in vitro resistance is detected.The triple antibiotic combination regimen has shown clinical and in vitro effectiveness in patients with CRAB infections(9).There is lack of studies exploring effectiveness of non colistin based antibiotics combination therapies for CRAB .Through this study we will try to compare effectiveness of non colistin based combination therapy for CRAB infections thereby preventing emergence of resistance to colistin. The primary aim of the study is comparison of treatment failure (defined as per protocol) with Minocycline versus Colistin Based Triple Antimicrobial Therapy for Carbapenem Resistant Acinetobacter Baumani Infection in Critical Care Unit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted in critical care unit of our hospital having either a bloodstream infection (BSI) and/or pneumonia due to MDR carbapenem resistant Acinetobacter Baumanni.
排除标准
- •Pregnant Patients,The presence of any of the following known clinical syndromes involving CRAB as a study pathogen which necessitate durations of antimicrobial therapies greater than 14 days: endocarditis, osteomyelitis, prosthetic joint infections, meningitis and/or other central nervous system infections.
- •Patients with known severe drug allergy to either of the study drugs or to β-lactams.
- •Patients with polymicrobial infections.
- •Refusal to participate in study.
结局指标
主要结局
Comparison of treatment failure after anti-CRAB treatment between minocycline versus colistin based triple antimicrobial therapy for carbapenem resistant Acinetobacter Baumannii Infection in critical care unit for a duration specified by protocol
时间窗: 3,5,7,10,12th day or within 24 hours after the end of study therapy
次要结局
- Comparison of microbiological response, all-cause mortality after 28 days, change in SOFA score from baseline, duration of mechanical ventilation, duration of ICU stay, incidence of toxicities related to treatment medications between minocycline versus colistin based triple antimicrobial therapy for carbapenem resistant Acinetobacter Baumanni Infection in critical care unit(3,5,7,10,12th day or within 24 hours after the end of study therapy)
研究者
Pooja Bhardwaj
AIIMS Rishikesh