Clinical Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Classification of ascites infection based on mNGS result.
研究概览
简要总结
Ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. Ascites infection including spontaneous bacterial peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared complications of ascites. The EASL guidelines recommend that diagnostic criteria of SBP is defined on the ascitic fluid polymorphonuclear leucocytes (PMN) count ≥250 cell/μl, with or without ascites fluid positive culture. However, in clinical practice. Up to 30% of hospitalized patients are considered as suspicious SBP, and treated as SBP without a laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized patients with ascites. Besides, fungal infection in ascites was aslo related to high mortality in cirrhosis patients.
Thus, to diagnose ascites infection promptly is the key step to prevent the complication. Since, the sensitivity of bacterial culture is limited even if ascites is directly injected into blood culture bottles at the besides. New method to identified the pathogen is needed.
Here, we aim to use metagenomic next-generation sequencing(mNGS) to provide the first-ever demonstration of precision medicine for the diagnosis of ascites infection in hospitalized patients, with immediate impact on clinical care and patients outcomes. The method of mNGS is undertaken by BGI Genomics Company which is a licensed clinical diagnostic laboratory in China. In this multicenter and prospective clinical study, we are planning to detect ascites sample by mNGS and compare the performance of mNGS and routine microbiological testing. Ultimately, we aim to improve the diagnosis of ascites infection and improve patients' outcomes.
详细描述
The study is divided into 2 parts:
Firstly, the study will test 3 types of sample by means of mNGS, including ascites fluid, peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and specificity of NGS.
Secondly, the clinical validation of mNGS will be performed in multicenters for ascites infection in cirrhosis patients. Furthermore, the study will collect the paired plasma sample for NGS testing at the same time to evaluate the protential sources of microorganisms in ascites.The aim of the study is to observe the performance of mNGS in ascites infection diagosis and the protential clinical effect in cirrhsis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization cirrhotic patients;
- •Age >18 years old;
- •Paitents with ascites at hospital admission.
排除标准
- •Pregnant women;
- •Hepatic tumor or extrahepatic related cancer;
- •Identified secondary peritonitis;
- •Ascites not related to portal hypertension;
- •Not provide written consent.
结局指标
主要结局
Classification of ascites infection based on mNGS result.
时间窗: within 1 month of patient enrollment in study.
Proportion of spontaneous bacterial peritonitis, bacterascites, neutrocytic ascites and sterile ascites based on mNGS result.
Clinical mNGS assay performance (mNGS positive number and the pathogenics species)
时间窗: within 1 month of patient enrollment in study
mNGS positive number and the pathogenics species in ascites
次要结局
- The proportion of acute kindey injury.(within 1 month of patient enrollment in study.)
- 90-day mortality(within 90 days of patient enrollment in study)
- The proportion of new-onset spontaneous bacterial peritonitis.(within 1 month of patient enrollment in study.)