Application of NGS in Ascites Infection

Application of Next Generation Sequence in the Etiological Diagnosis of Abdominal Infection in Patients With Liver Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Ascites Infection
• Intervention / Treatment: Diagnostic test: Next generation sequence

Detailed Description

This study is observational and approximately 50 subjects will be included according to inclusion and exclusion criteria. Patients who meet the inclusion and exclusion criteria, will be were collected a sufficient amount of ascites, and the collected ascites will be divided into four different groups. One group will be used as a control, and the other three groups will be centrifugated at different speeds. After centrifugation, the four groups of specimens will be tested by NGS to detect the pathogens. By comparing the detection rate of NGS test for concentrated samples and unconcentrated samples, and this study aims to observe whether centrifugation could increase the detection rate. By comparing the results of NGS and the results of traditional detection methods, this study also aims to explore the consistency between NGS and traditional detection methods, and whether NGS has higher detection rates.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Taiyu He, Master; Phone Number: +86 18423504023; Email: 624055080@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Dazhi Zhang, M.D.; Email: 300595@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ascites infection

Description

Inclusion Criteria:

1. Willing and able to sign informed consent;
2. Age ≥ 18 years old;
3. Have full civil capacity;
4. The amount of ascites is suitable for puncture;
5. 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.)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Next generation sequence will be used to detect the pathogens in ascites.; Other Names: Traditional detection method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Director: Dazhi Zhang, M.D., The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): March 25, 2023
• Study Completion (Anticipated): April 25, 2023

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Infections; Communicable Diseases; Ascites
• Other Study ID Numbers: Zhangdz2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No