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临床试验/CTRI/2026/01/100500
CTRI/2026/01/100500尚未招募不适用

Risk factors and outcomes of patients with metallo-beta-lactamase-producing gram-negative bloodstream bacterial infections in ICU: a prospective observational study.

Sir Gangaram Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
试验地点
1

研究概览

简要总结

Phenotypic detection of MBLs (e.g., combined disk tests with EDTA) is routinely available in many labs but it is not a molecular diagnostic method. Molecular assays (PCR for common bla genes) like BCID 2 (BioFire Blood Culture Identification 2) provide faster, gene specific identification and are now widely used in clinical settings.

Our prospective observational study will enrol 600 patients with BCID 2 confirmed carbapenemase producing blood stream infection after obtaining informed consent. Current antibiotic use and its duration will not affect enrolment decision. The study will be limited to gram negative bacterial infections by Acinetobacter baumanii complex, Pseudomonas aeruginosa, and Enterobacterales (Klebsiella spp. & E. coli only).

 All carbapenemase producing study bacteria will be grouped in to MBL producers and MBL non producers.  Predefined risk factors in both the groups will be studied along with 28-day all-cause mortality and ICU length of stay (ICU LOS). Incidence of MBL GNB in BCID 2 samples will also be calculated.

 This study might help to find the current incidence of blood stream gram-negative infections with MBL’s, associated patient risk factors and mortality in the setting of a tertiary care ICU. This will help to frame empiric antibiotic policy in the ICU patients in the presence of studied risk factors.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult patients in intensive care unit found to have gram negative bacteria (GNB) positive blood stream infection.

排除标准

  • Patients already enrolled in any therapeutic intervention study.
  • Patients who have a lab-confirmed bloodstream MBL infection at the time of admission to the ICU.
  • Refusal to participate in the study.

研究者

发起方
Sir Gangaram Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr. Prasoon Gupta

Institute of Critical care Medicine

研究点 (1)

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