Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Cirrhosis, Liver

Study type: Observational

Funder types: Other

Identifiers

NCT06039696

NFEC-2020-255

Details and patient eligibility

About

The goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. The main questions it aims to answer are:

1. mNGS testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy.
2. Proportion of patients with re-compensation.
3. The positive rate of mNGS in patients with acute decompensated cirrhosis and the characteristics of pathogen.
4. The incidence, risk factors and clinical correlation of CMV reactivation.

Full description

Metagenomic next-generation sequencing (mNGS) is emerging as an important culture-independent technique that can detect nearly all known pathogens simultaneously from a clinical sample.Sequencing of microbial cell-free DNA (cfDNA) has recently been shown to enable diagnosis of several infection. Relevant studies on the clinical application of mNGS in cirrhosis patients are rare. The primary aim of this study was to comprehensively evaluate the fragments of genomic DNA from circulating microorganisms in acutely decompensated cirrhosis patients by sequencing the microbial cfDNA and relate this to clinical outcomes. The secondary aim was to validate the potential role of CMV reactivation, a known NHV with available antiviral medicines, in determining the prognosis of decompensated cirrhosis patients.

Enrollment: 850 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old.
• Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
• Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy.

Exclusion criteria

• Age > 80 years old.
• Malignancy of liver or other organs (including leukemia).
• Receiving immunosuppressive agents for non-hepatic diseases.
• HIV infection.

Trial design

850 participants in 1 patient group

patients received mNGS test

Description:

After enrolment, patients will receive mNGS test.