Comparison of Clinical Outcomes in Bloodstream Infections With Carbapenem Hetero-resistant vs Carbapenem Resistant Klebsiella Pneumoniae (COMBAT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 30-day crude mortality
研究概览
简要总结
COMBAT trial was contemplated to elucidate unknown clinical relevance of carbapenem heteroresistance among Klebsiella pneumoniae species. Bloodstream infections, type of frequently seen invasive infections that pathogen isolation, identification of antimicrobial resistance mechanisms can be performed efficiently, with carbapenem resistant Klebsiella pneumoniae (CRKp) and carbapenem hetero-resistant Klebsiella pneumoniae will be compared in terms of relevant clinical outcomes such as 30-day mortality rate, 14-day clinical cure rate, 7-day microbiological eradication rate and 90-day relapse/re-infection rate. In addition, underlying molecular resistance mechanisms causing carbapenem hetero-resistance among Klebsiella pneumoniae isolates will be investigated by using whole genome sequences.
详细描述
Main Objectives:
- Conceiving the clinical relevance of carbapenem hetero-resistance phenomenon among Klebsiella pneumoniae strains.
- Identification of molecular resistance mechanisms causing carbapenem hetero-resistance among Klebsiella pneumoniae strains
- Identification of accuracy of gradient test (e.g. E-test) and disc diffusion test for detection of carbapenem heteroresistance as compared with gold standard PAP analysis
Hypothesis
Main hypothesis
1- 30-day mortality rate is higher in bloodstream infections caused by CRKp than carbapenem hetero-resistant Klebsiella pneumoniae
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All adult (≥18 years) patients who have monobacterial BSI with CRKp or carbapenem hetero-resistant Klebsiella pneumoniae except palliative patients and pregnant or breast-feeding patients
排除标准
- •• <18 years old patients
- •Palliative patients
- •Pregnant or breast-feeding patients
- •Subsequent BSI episodes in the same patients (only first episode will be included)
- •Polimicrobial bacteremia
- •Patients who are not followed and treated by infectious diseases physicians
- •Patients who die within 24 hours after onset of BSI which is defined as the time in which the sample for blood culture is taken.
研究组 & 干预措施
Carbapenem resistant Klebsiella pneumoniae group
Participants having bloodstream infection caused by carbapenem-resistant Klebsiella pneumoniae and systemic signs of infection. Only first bloodstream infection episode will be included for each participant
干预措施: Monotherapy and combination therapy (all antibiotics that are given by attending pysicians and can be active against Klebsiella pneumoniae will be evaluated) (Drug)
Carbapenem hetero-resistant Klebsiella pneumoniae group
Participants having bloodstream infection caused by carbapenem-heteroresistant Klebsiella pneumoniae and systemic signs of infection. Only first bloodstream infection episode will be included for each participant
干预措施: Monotherapy and combination therapy (all antibiotics that are given by attending pysicians and can be active against Klebsiella pneumoniae will be evaluated) (Drug)
结局指标
主要结局
30-day crude mortality
时间窗: 30-day
Death by any cause
次要结局
- 14-day clinical response(14-days)
- 90-day relapse or re-infection(90-days)