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

NCT06039696 | Recruiting

• 1 other identifier: NFEC-2020-255
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Positive rate of mNGS test in AD patients

  at enrolment

Secondary Outcomes (7)

• 90-day transplantation-free mortality

  From enrollment to 90 days

• Incidence of acute kidney injury (AKI)

  From enrollment to 90 days

• Proportion of hospital readmissions due to infections

  From enrollment to 90 days

• Proportion of progression to SIRS or sepsis

  From enrollment to 90 days

• Consistency with blood culture results

  at enrollment

Study Arms (1)

patients received mNGS test

After enrolment, patients will receive mNGS test.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with diagnosis of cirrhosis hospitalized for acute decompensation

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, feces

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen Jinjun

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Jinjun

CONTACT

+86 020 62787310; chjj@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 15, 2023
• Study Start: February 10, 2021
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)