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临床试验/CTRI/2024/09/074195
CTRI/2024/09/074195尚未招募不适用

Phenotypic Detection and Genotypic Characterization of colistin resistance in Gram-negative bacilli

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
1. To detect the presence of the mcr-1 gene and its variants in Gram-Negative Bacilli which may lead to low/high-level colistin resistance.

研究概览

简要总结

Antimicrobial resistance (AMR) is a global health and development threat. World Health Organization (WHO) has declared that AMR is one of the top ten global public health threats facing humanity. Resistance to colistin is steadily rising in Gram-negative bacilli. Hence, there is a need to analyze their resistance profile, and mechanisms and look for alternate treatment options. The primary objectives are to detect the presence of the mcr-1 gene and its variants in Gram-Negative Bacilli which may lead to low/high-level colistin resistance and to evaluate various phenotypic tests for determining colistin resistance in comparison to Broth Microdilution. the secondary objectives are to determine susceptibility to currently available and newer treatment options as alternatives to colistin and to determine genes encoding for Carbapenemase and Extended-Spectrum Beta-Lactamase (ESBLs). The study will be carried out in the Department of Microbiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. Stocked Gram-negative bacterial isolates from all clinical specimens routinely submitted for bacterial culture and susceptibility testing will be included in the study. No patient data will be collected. No patient specimen will be collected for the study.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Gram-negative bacilli isolated and stocked from any clinical sample routinely submitted for a bacterial culture that tests resistance to colistin by broth microdilution method as well as carbapenem-resistance gram-negative bacteria.

排除标准

  • Gram-negative bacilli with intrinsic resistance to colistin.

结局指标

主要结局

1. To detect the presence of the mcr-1 gene and its variants in Gram-Negative Bacilli which may lead to low/high-level colistin resistance.

时间窗: 3 YEARS

2. To evaluate various phenotypic tests for determining colistin resistance in comparison to Broth Microdilution

时间窗: 3 YEARS

次要结局

  • 1. To determine susceptibility to currently available and newer treatment options as alternatives to colistin(2. To determine genes encoding for Carbapenemase and Extended-Spectrum Beta-Lactamase (ESBLs))

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Manisha

Maulana Azad Medical College

研究点 (1)

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