Application of NGS in Ascites Infection

August 8, 2022 updated by: The Second Affiliated Hospital of Chongqing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Results of next generation sequence
Time Frame: within 10 days of patient enrollment in study
Pathogens detected by NGS
within 10 days of patient enrollment in study
Results of traditional detection methods
Time Frame: within 10 days of patient enrollment in study
Pathogens detected by traditional detection methods
within 10 days of patient enrollment in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Second Affiliated Hospital of Chongqing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dazhi Zhang, M.D., The Second Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Clinical Trials on Next generation sequence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings