Turkish Prospective Cohort Study on Carbapenem Resistant Klebsiella Pneumonia Bacteremia: a National Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 15
- 主要终点
- 30-day crude mortality
研究概览
简要总结
Carbapenem-resistant Klebsiella pneumonia (CRKp) blood stream infections (BSI) cause substantial mortality among hospitalized patients. Treatment options for CRKp infections are limited and increasing resistance rates to few available drugs, i.e., colistin, is a big concern. This prospective multicenter observational study is designed to describe clinical characteristics and outcomes of patients with CRKp bacteremia in an oxacillinase-48 (OXA-48) endemic country to define predictors of mortality with a focus on the impact of mono versus combination therapies on mortality. The study will also investigate risk factors associated with colistin-resistant CRKp BSI.
详细描述
OBJECTIVES
MAIN OBJECTIVE
- To compare the impact of combination therapy and monotherapy on mortality for patients with CRKp BSI
SECONDARY OBJECTIVES 2. To identify predictors of mortality for patients with CRKp BSI 3. To compare the impact of appropriate and inappropriate empiric and targeted therapies on mortality for patients with CRKp BSI 4. To identify the risk factors for colistin resistance among patients with ColR CRKp BSI.
HYPOTHESES
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (≥18 years old) with clinically significant CRKp bacteremia
排除标准
- •Polymicrobial infection (except coagulase-negative staphylococci or other skin contaminants isolated from one blood culture bottle, which is considered contamination)
- •Subsequent CRKp bacteremia episodes from the same patient
研究组 & 干预措施
Patients with CRKp BSI:Combination therapy
干预措施: Combination therapy (Drug)
结局指标
主要结局
30-day crude mortality
时间窗: 1 month
Death by any cause
次要结局
- Duration of antibiotic treatment(1 month)
- Recurrence(1 month)
- In-hospital mortality(1 month)
- Microbiologic eradication(day 3, 7 and/or 14)
- Infection related mortality(1 month)
- Colistin resistance development(1 month)
- Nephrotoxicity(1 month)
- Clinical response at day 7 and 14(day 7 and 14)
- Superinfection(1 month)
- Duration of hospital stay after infection(1 month)
- ICU stay after infection(1 month)
研究者
Burcu Isler
Coordinator
Sisli Hamidiye Etfal Training and Research Hospital