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临床试验/NCT07369518
NCT07369518尚未招募不适用

Effect of Ceftazidime-Avibactam Against Carbapenemase-Positive Klebsiella Pneumoniae Causing Health Care-Associated Infections

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
1 ISOLATION OF KLEB. by culture on macConkey agar

研究概览

简要总结

Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.

Bacterial identification by Gram stain, culture and biochemical rections

  • analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
  • phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.

详细描述

Carbapenem-resistant Enterobacterales (CRE) poses an urgent global public health threat, with more than 1,100 documented deaths, as reported in a 2019 antibiotic resistance publication by the U.S. Centers for Disease Control and Prevention.

Carbapenem-resistant Enterobacterales, including carbapenem-resistant Klebsiella pneumoniae (CRKP), is associated with higher mortality compared with infections caused by carbapenem-susceptible Enterobacterales infections Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.

Bacterial identification by Gram stain, culture and biochemical rections

  • analysisThe resistance pattern of the isolates will be detected by disc diffusion method.
  • phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.-

排除标准

  • Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.

研究组 & 干预措施

Group 1 patients with klebsiella pneumoniae infection

Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.

干预措施: . - Genotypic detection of carbapenemase genes by conventional PCR. (Genetic)

Group 2 patients without klebsiella pneumoniae

Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.

干预措施: . - Genotypic detection of carbapenemase genes by conventional PCR. (Genetic)

结局指标

主要结局

1 ISOLATION OF KLEB. by culture on macConkey agar

时间窗: 6 months from January to may

Antibiotic sensitivity testing of different antibiotics according to clsi 25

时间窗: 6 months from January to may

Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae

时间窗: 6 months from January to may

Detection of resistance gene in isolates using conventional pcr

时间窗: 6 months from June to December

Detection of some virulence genes using conventional pcr

时间窗: 6 months from June to December

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walaa ismail Marzouk

Demonstrator at medical microbiology and immunology department faculty of medicine so

Sohag University

研究点 (1)

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