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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-10

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cirrhosis, Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients received mNGS test

After enrolment, patients will receive mNGS test.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No