Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
Overview
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.
Detailed 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.
Primary outcome measures
- Positive rate of mNGS test in AD patients [Time frame: at enrolment]
Secondary outcome measures (7)
- 90-day transplantation-free mortality [Time frame: From enrollment to 90 days]
- Incidence of acute kidney injury (AKI) [Time frame: From enrollment to 90 days]
- Proportion of hospital readmissions due to infections [Time frame: From enrollment to 90 days]
- Proportion of progression to SIRS or sepsis [Time frame: From enrollment to 90 days]
- Consistency with blood culture results [Time frame: at enrollment]
- Incidence of CMV reactivation [Time frame: From enrollment to 90 days]
- Rate of progression to acute-on-chronic liver failure (ACLF) [Time frame: From enrollment to 90 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanfang Hospital — Guangzhou
Identifiers
NCT: NCT06039696 · NFEC-2020-255