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

Sponsor
Nanfang Hospital, Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06039696
Collaborator
(none)
480
Enrollment
1
Location
37.7
Anticipated Duration (Months)
12.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    480 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
    Actual Study Start Date :
    Feb 10, 2021
    Actual Primary Completion Date :
    Jun 30, 2021
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients received mNGS test

    After enrolment, patients will receive mNGS test.

    Outcome Measures

    Primary Outcome Measures

    1. Positive rate of mNGS test in AD patients [at enrolment]

    Secondary Outcome Measures

    1. 28- and 90-day transplantation-free mortality [at 28-day and 90-day after enrolment]

    2. The rate of development of acute kidney injury and acute-on-chronic liver failure [up to 12 weeks]

    3. Proportion of hospital readmissions due to infections [up to 12 weeks]

    4. Proportion of progression to SIRS or sepsis [up to 12 weeks]

    5. Consistency with blood culture results [at enrollment]

      Concordance of mNGS With Other traditional Testing on Pathogens

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanfang Hospital Guangzhou Guangdong China

    Sponsors and Collaborators

    • Nanfang Hospital, Southern Medical University

    Investigators

    • Principal Investigator: Chen Jinjun, Nanfang Hospital, Southern Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanfang Hospital, Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT06039696
    Other Study ID Numbers:
    • NFEC-2020-255
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 15, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Sep 15, 2023