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临床试验/CTRI/2024/02/062846
CTRI/2024/02/062846招募中不适用

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.

Dr Deepak Govil17 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年2月29日最近更新:

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

发起方
Dr Deepak Govil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Deepak Govil

Medanta The Medicity, Gurgaon,

研究点 (17)

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