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

Ascites Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125654
• Other study ID #: 010
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen
• Phone: 0086-18588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hospitalization cirrhotic patients;

2. Age >18 years old;

3. Paitents with ascites at hospital admission.

Exclusion Criteria:

1. Pregnant women;

2. Hepatic tumor or extrahepatic related cancer;

3. Identified secondary peritonitis;

4. Ascites not related to portal hypertension;

5. Not provide written consent.

Related Conditions & MeSH terms

• Ascites
• Ascites Infection
• Communicable Diseases
• End Stage Liver Disease
• Infection
• Liver Diseases
• Peritonitis

Intervention

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.

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Beijing Ditan Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Jilin University, Mengchao Hepatobiliary Hospital of Fujian Medical University, RenJi Hospital, Shanghai Public Health Clinical Center, Southwest Hospital, China, Taihe Hospital, The Second Hospital of Shandong University, Wuhan Union Hospital, China, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The proportion of acute kindey injury.	The proportion of acute kindey injury between ascites NGS positive and negative groups.	within 1 month of patient enrollment in study.
Secondary	90-day mortality		within 90 days of patient enrollment in study
Secondary	The proportion of new-onset spontaneous bacterial peritonitis.		within 1 month of patient enrollment in study.