Application of NGS in Ascites Infection

NCT05352152 | Unknown

• 1 other identifier: Zhangdz2022
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Liver cirrhosis is a common serious chronic disease. There are about 123 million patients with liver cirrhosis worldwide, and about 1 million people die of liver cirrhosis every year. The proportion of bacterial infection in hospitalized patients with liver cirrhosis is between 25% and 46%, among which spontaneous bacterial peritonitis (SBP) is the most common type of infection in patients with liver cirrhosis. After early and reasonable diagnosis and treatment, the mortality of cirrhotic patients with SBP can be reduced from more than 90% to about 20%. Therefore, rapid and accurate diagnosis is of great help to improve the prognosis of cirrhotic patients with SBP. However, at present, the traditional detection methods is time-consuming with a low detection rate, and can not detect intracellular bacteria and some other types of pathogens. Next-generation sequencing (NGS) is a relatively new detection technology which can detect the nucleic acid sequence information in a high-throughput, large-scale way. It can detect the pathogens comprehensively, fast and accurately. In recent years, NGS has gradually transitioned from a research tool to a diagnostic method. Many studies have shown that NGS has better application value in bloodstream infections, ocular infectious diseases, central nervous system infectious diseases and respiratory infectious diseases. However, there is still a lack of research on the use of NGS for the detection of pathogenic microorganisms in ascites. Therefore, by comparing the next generation sequence (NGS) and traditional detection technology in the detection of pathogens in ascites, this study aimed to evaluate the value of NGS in the pathogenic diagnosis of ascites infection.

Conditions

Ascites Infection; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• Results of next generation sequence

  Pathogens detected by NGS

  within 10 days of patient enrollment in study

• Results of traditional detection methods

  Pathogens detected by traditional detection methods

  within 10 days of patient enrollment in study

Study Arms (1)

Patients with ascites infection

Patients who is confirmed with ascites infection or clinically diagnosed as ascites infection will be enrolled in this cohort.

Diagnostic Test: Next generation sequence

Interventions

Next generation sequence DIAGNOSTIC_TEST

Next generation sequence will be used to detect the pathogens in ascites.

Also known as: Traditional detection method

Patients with ascites infection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ascites infection

You may qualify if:

• Willing and able to sign informed consent;
• Age ≥ 18 years old;
• Have full civil capacity;
• The amount of ascites is suitable for puncture;
• Ascites infection confirmed by clinical etiology test or clinically suspected ascites infection (such as elevated leukocyte count, elevated procalcitonin, abdominal inflammation indicated by imaging, etc.)

You may not qualify if:

• Those who cannot cooperate with the test;
• Those whose samples cannot be obtained by puncture;
• The cause of ascites is clear;
• Those who are considered to be not suitable for this study

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Dazhi Zhang, M.D.

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Taiyu He, Master

CONTACT

+86 18423504023; 624055080@qq.com

Study Design

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

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: April 28, 2022
• Study Start: July 1, 2022
• Primary Completion: March 25, 2023
• Study Completion: April 25, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)