跳至主要内容
临床试验/CTRI/2026/03/105773
CTRI/2026/03/105773尚未招募不适用

A Prospective Observational Study on Antibiotic De-escalation Practices and Outcomes in ICU Patients with Suspected or Confirmed Infections

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年3月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1

研究概览

简要总结

This prospective observational study evaluates antibiotic de-escalation practices and associated outcomes in adult ICU patients with suspected or confirmed infections receiving broad spectrum antibiotics. Conducted in the medical and surgical ICUs of Tata Memorial Hospital and ACTREC, the study includes adults admitted to ICU for more than 48 hours who receive broad-spectrum antibiotics within the first 48 hours of admission. ADE is defined as narrowing antibiotic spectrum, stopping combination agents, or discontinuing empiric coverage for non-isolated pathogens.

The primary outcome is the rate of ADE, while secondary outcomes include early discontinuation of antibiotics, duration of therapy, factors influencing ADE decisions, ICU and hospital length of stay, mortality, and incidence of Clostridium difficile infection. Patients are followed until ICU discharge or death, with data collected on demographics, severity scores, microbiology, and antibiotic use. The study aims to generate real-world evidence on ADE frequency, safety, and clinical impact in ICU settings, supporting antimicrobial stewardship efforts

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults more than 18 years admitted to ICU
  • Broad spectrum antibiotic use in first 48 hours of ICU admission
  • Expected ICU stay more than or equal to 48 hours.

排除标准

  • Advanced malignancy with Best supportive care.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Amol Kothekar

ACTREC, Tata Memorial Centre

研究点 (1)

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