A retrOspective, multi-centre study to evalUate the effecTiveness of different antibiotics/ Combinations being used in patients with bloOd stream infection and/ or hospital acquired pneuMonia caused by CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 17
- 主要终点
- 1. Clinical outcomes of patient with BSI
研究概览
简要总结
This is a retrospective, multi-centre study to evaluate the effectiveness of different antibiotics/ combinations being used in patients with blood stream infection and/ or hospital acquired pneumonia caused by CRE (carbapenem resistant enterobacterales-Klebsiella pneumoniae, Escherichia coli), CRAB (Carbapenem resistant Acinetobacter baumanii) & CRPA (carbapenem resistant Pseudomonas aeruginosa). Inclusion criteria for the study includes, adults (≥18 years of age inclusive) with confirmed culture based diagnosis of hospital acquired pneumonia (HAP) (pneumonia developing at least 48 hours after hospital admission) and or blood stream infection caused by CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA, and those who have received antibiotic mono-/ combination therapy for at-least 48hours as per clinician’s discretion. Exclusion criteria includes, culture positive from any site other than blood stream/ pneumonia; any organism other than CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA isolated within 14 days of initiation/ EOT of antibiotic therapy. Primary outcomes of the study are ‘clinical outcomes of patient with BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; ‘clinical outcomes of patient with HAP at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; clinical outcomes of patient with HAP plus BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; ‘microbiological outcome in patients with BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’; ‘microbiological outcome in patients with HAP at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’; ‘microbiological outcome in patients with HAP plus BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’. Secondary outcomes of the study are duration of invasive mechanical ventilation, duration of vasopressor requirement, need for renal replacement therapy, length of hospital stay, length of ICU stay, ICU outcome, and hospital outcome.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult more than 18 years of age with confirmed culture based diagnosis of hospital acquired pneumonia (HAP) (pneumonia developing at least 48 hours after hospital admission) and / or blood stream infection caused by CRE (Klebsiella pneumoniae, Escherichia coli) CRAB & CRPA Received antibiotic mono and or combination therapy for at-least 48 hours as per clinician’s discretion.
排除标准
- •Culture positive from any site other than blood stream/ pneumonia.
- •Any organism other than CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA isolated within 14 days of initiation/ EOT of antibiotic therapy.
结局指标
主要结局
1. Clinical outcomes of patient with BSI
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
2. Clinical outcomes of patient with HAP
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
3. Clinical outcomes of patient with HAP plus BSI
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
4. Microbiological outcome in patients with BSI
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
5. Microbiological outcome in patients with HAP
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
6. Microbiological outcome in patients with HAP plus BSI
时间窗: Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
次要结局
- 1. Duration of invasive mechanical ventilation (hours)(2. Duration of vasopressor requirement (hours))
研究者
Dr Deepak Govil
Medanta The Medicity, Gurgaon,
