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

NCT04125654 | Unknown DMC

• 1 other identifier: 010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ascites infection; ascites; mNGS

Outcome Measures

Primary Outcomes (2)

• Clinical mNGS assay performance (mNGS positive number and the pathogenics species)

  mNGS positive number and the pathogenics species in ascites

  within 1 month of patient enrollment in study

• Classification of ascites infection based on mNGS result.

  Proportion of spontaneous bacterial peritonitis, bacterascites, neutrocytic ascites and sterile ascites based on mNGS result.

  within 1 month of patient enrollment in study.

Secondary Outcomes (3)

• 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.

Study Arms (1)

Patients with ascites enrolled for mNGS testing

EXPERIMENTAL

Patients with ascites will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective clinical documents).

Device: mNGS for pathogen detection

Interventions

mNGS for pathogen detection DEVICE

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

Also known as: metagenomic next-generation sequencing testing

Patients with ascites enrolled for mNGS testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization cirrhotic patients;
• Age \>18 years old;
• Paitents with ascites at hospital admission.

You may not qualify if:

• Pregnant women;
• Hepatic tumor or extrahepatic related cancer;
• Identified secondary peritonitis;
• Ascites not related to portal hypertension;
• Not provide written consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• Beijing Ditan Hospital: collaborator
• Shanghai Public Health Clinical Center: collaborator
• Taihe Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Southwest Hospital, China: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The Second Hospital of Shandong University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• RenJi Hospital: collaborator

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aishan Su

  Nanfang Hospital Guangzhou, Guangdong, China, 510515

  STUDY DIRECTOR

Central Study Contacts

Jinjun Chen

CONTACT

0086-18588531001; chjj@smu.edu.cn

Beiling Li

CONTACT

0086-13570541527; lbling123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 14, 2019
• Study Start: August 12, 2019
• Primary Completion: November 30, 2020
• Study Completion: February 28, 2021
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

CN (1)