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临床试验/NCT06197984
NCT06197984已完成不适用

Exploring Antimicrobial Resistance in Patients With Acute Cholangitis Undergoing ERCP: A Prospective Multicentre Study

Emergency County Hospital Pius Brinzeu; Timisoara, Romania2 个研究点 分布在 1 个国家目标入组 1,435 人开始时间: 2024年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,435
试验地点
2
主要终点
Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile

研究概览

简要总结

This study prospectively explores antimicrobial resistance in patients with acute cholangitis undergoing ERCP procedures. By analyzing patient profiles, microbial cultures, and treatment outcomes, the current study seeks to identify specific patterns of resistance, assess the effectiveness of current antimicrobial therapies, and explore potential strategies to optimize treatment regimens.

详细描述

Given the extensive utilization of antibiotics and the worldwide rise of multidrug-resistant organisms, there are ongoing initiatives to ascertain microbiological traits and discern patterns of drug resistance associated with intra-abdominal infections.

Microbial cultures from bile and blood samples will be established and characterized using appropriate methodologies. For patients with moderate and severe acute cholangitis (AC), blood cultures will be initiated upon admission, adhering to the Tokyo Guidelines for AC 2018 recommendations. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention. Initially, a minimum of 5 mL of the procured bile will be discarded, followed by the collection of an additional 5 mL in a sterile vessel containing a medium conducive to both anaerobic and aerobic bacterial cultures. The samples will undergo a minimum incubation period of seven days at 37 °C until microbial proliferation becomes evident. Antibiotic susceptibility assessments, specifically minimum inhibitory concentration (MIC), will be performed and interpreted according to established guidelines.The analysis of samples will occur within the laboratory of each respective center, with antibiograms conducted in accordance with established protocols.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute cholangitis
  • Ability to provide an informed consent
  • Age over 18 years
  • Any gender

排除标准

  • Age under 18
  • Pregnancy
  • Post-ERCP perforation
  • The patient's decision to abstain from study enrollment
  • Patients unable to express informed consent
  • Patients from whom a bile sample could not be collected.

研究组 & 干预措施

Patients with acute cholangitis

Patients admitted to the hospital due to acute cholangitis and undergoing ERCP will be selected. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention.

干预措施: ERCP (Procedure)

结局指标

主要结局

Exploring antimicrobial resistance of bile cultures and characterizing bacterial profile

时间窗: 2 years

The primary objective of this prospective, multicenter study is to meticulously characterize the bacterial profile and assess the antimicrobial resistance of bile cultures in patients diagnosed with acute cholangitis undergoing ERCP procedures. By employing advanced microbiological analyses, the investigators aim to identify specific bacterial strains and their resistance profiles, providing comprehensive insights into the dynamics of infection. This primary outcome will contribute to the development of tailored antimicrobial strategies, optimizing the management and treatment outcomes for individuals with acute cholangitis.

次要结局

  • ERCP naive patients vs. patients with a history of ERCP(2 years)
  • Multidrug-Resistance (MDR)(2 years)
  • Isolated bacteria and the etiology of obstructive biliary disease(2 years)

研究者

发起方
Emergency County Hospital Pius Brinzeu; Timisoara, Romania
申办方类型
Network
责任方
Principal Investigator
主要研究者

Bogdan Miutescu, MD

MD,PhD

Emergency County Hospital Pius Brinzeu; Timisoara, Romania

研究点 (2)

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