Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases

Summary

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.

Conditions

• Ascites Infection

Interventions

DEVICE

mNGS for pathogen detection

This assay is a metagenomic test undertaken by BGI Genomics Co., Ltd. for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.

Sponsors & Collaborators

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Taihe Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Aishan Su · Nanfang Hospital Guangzhou, Guangdong, China, 510515

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-12

Primary Completion

2020-11-30

Completion

2021-02-28

Countries

• China

Study Locations