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临床试验/NCT04131751
NCT04131751已完成不适用

Establishing of Next Genaration Sequencing Methods for Microbiological Diagnostic of Ascitic Fluid Infections

University Hospital Freiburg1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
The comparative assessment of about 50 patients

研究概览

简要总结

Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.

研究设计

研究类型
Observational
观察模型
Other
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

  • Male and female patients ≥ 18 years of age
  • Samples from patients who have ascites puncture to exclude infection
  • Written consent of the patient after clarification

排除标准

  • Minor patients
  • Non-consenting patients
  • Samples without sufficient residual material after standard diagnostics
  • Samples from patients who have not consented to the examination.

结局指标

主要结局

The comparative assessment of about 50 patients

时间窗: 12-18 Months

次要结局

未报告次要终点

研究者

发起方
University Hospital Freiburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Tarek Badr

Principal Investigator

University Hospital Freiburg

研究点 (1)

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