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Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Nanfang Hospital
Guangzhou, Guangdong, China
Start Date
February 10, 2021
Primary Completion Date
December 30, 2024
Completion Date
March 30, 2025
Last Updated
October 15, 2024
850
ESTIMATED participants
Lead Sponsor
Nanfang Hospital, Southern Medical University
NCT07343037
NCT05982769
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03208868