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

Cirrhosis, Liver Clinical Trial

Official title:

Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039696
• Other study ID #: NFEC-2020-255
• Status: Recruiting
• Start date: February 10, 2021
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Chen Jinjun
• Phone: +86 020 62787310
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: April 2024
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of mNGS test in AD patients		at enrolment
Secondary	28- and 90-day transplantation-free mortality		at 28-day and 90-day after enrolment
Secondary	The rate of development of acute kidney injury and acute-on-chronic liver failure		up to 12 weeks
Secondary	Proportion of hospital readmissions due to infections		up to 12 weeks
Secondary	Proportion of progression to SIRS or sepsis		up to 12 weeks
Secondary	Consistency with blood culture results	Concordance of mNGS With Other traditional Testing on Pathogens	at enrollment