Clinical trial NCT06039696: Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection
Official title: Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis, Liver
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnosis of cirrhosis hospitalized for acute decompensation

Brief summary: 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.

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.

Primary outcomes:
measure: Positive rate of mNGS test in AD patients
timeFrame: at enrolment
Secondary outcomes:
measure: 90-day transplantation-free mortality
timeFrame: From enrollment to 90 days
measure: Incidence of acute kidney injury (AKI)
timeFrame: From enrollment to 90 days
measure: Proportion of hospital readmissions due to infections
timeFrame: From enrollment to 90 days
measure: Proportion of progression to SIRS or sepsis
timeFrame: From enrollment to 90 days
measure: Consistency with blood culture results
timeFrame: at enrollment
measure: Incidence of CMV reactivation
timeFrame: From enrollment to 90 days
measure: Rate of progression to acute-on-chronic liver failure (ACLF)
timeFrame: From enrollment to 90 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Chen Jinjun
role: PRINCIPAL_INVESTIGATOR
References: