Ascites InfectionNCT04125654
Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases
A study testing mNGS for pathogen detection in people with Ascites Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. Ascites infection including spontaneous bacterial peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared complications of ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites Infection
- What is being tested?
- mNGS for pathogen detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization cirrhotic patients;
- Age >18 years old;
- Paitents with ascites at hospital admission.
Who cannot join
- Pregnant women;
- Hepatic tumor or extrahepatic related cancer;
- Identified secondary peritonitis;
- Ascites not related to portal hypertension;
- Not provide written consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Jinjun Chen, +8615521287260, chjj@smu.edu.cn
Jinjun Chen
About this study
Official title: Clinical Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases
Ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. Ascites infection including spontaneous bacterial peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared complications of ascites. The EASL guidelines recommend that diagnostic criteria of SBP is defined on the ascitic fluid polymorphonuclear leucocytes (PMN) count ≥250 cell/μl, with or without ascites fluid positive culture. However, in clinical practice. Up to 30% of hospitalized patients are considered as suspicious SBP, and treated as SBP without a laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized patients with ascites. Besides, fungal infection in ascites was aslo related to high mortality in cirrhosis patients.
Thus, to diagnose ascites infection promptly is the key step to prevent the complication. Since, the sensitivity of bacterial culture is limited even if ascites is directly injected into blood culture bottles at the besides. New method to identified the pathogen is needed.
Here, we aim to use metagenomic next-generation sequencing(mNGS) to provide the first-ever demonstration of precision medicine for the diagnosis of ascites infection in hospitalized patients, with immediate impact on clinical care and patients outcomes. The method of mNGS is undertaken by BGI Genomics Company which is a licensed clinical diagnostic laboratory in China. In this multicenter and prospective clinical study, we are planning to detect ascites sample by mNGS and compare the performance of mNGS and routine microbiological testing. Ultimately, we aim to improve the diagnosis of ascites infection and improve patients' outcomes.
Read the detailed description
The study is divided into 2 parts:
Firstly, the study will test 3 types of sample by means of mNGS, including ascites fluid, peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and specificity of NGS.
Secondly, the clinical validation of mNGS will be performed in multicenters for ascites infection in cirrhosis patients. Furthermore, the study will collect the paired plasma sample for NGS testing at the same time to evaluate the protential sources of microorganisms in ascites.The aim of the study is to observe the performance of mNGS in ascites infection diagosis and the protential clinical effect in cirrhsis patients.
- Conditions
- Ascites Infection
- Being tested
- mNGS for pathogen detection
- Keywords
- Ascites infection, ascites, mNGS
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGS for pathogen detectionDevice
Also called metagenomic next-generation sequencing testing
This assay is a metagenomic test undertaken by BGI Genomics Co., Ltd. for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ascites enrolled for mNGS testing | Experimental | Patients with ascites will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective clinical documents). Receives: Device: mNGS for pathogen detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical mNGS assay performance (mNGS positive number and the pathogenics species)
mNGS positive number and the pathogenics species in ascites
Measured: within 1 month of patient enrollment in study
Classification of ascites infection based on mNGS result.
Proportion of spontaneous bacterial peritonitis, bacterascites, neutrocytic ascites and sterile ascites based on mNGS result.
Measured: within 1 month of patient enrollment in study.
Secondary outcomes (3)
The proportion of acute kindey injury.
The proportion of acute kindey injury between ascites NGS positive and negative groups.
Measured: within 1 month of patient enrollment in study.
90-day mortality
Measured: within 90 days of patient enrollment in study
The proportion of new-onset spontaneous bacterial peritonitis.
Measured: within 1 month of patient enrollment in study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start12 Aug 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascites InfectionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Hospital of Jilin University, Beijing Ditan Hospital, Shanghai Public Health Clinical Center, Taihe Hospital, Xiangya Hospital of Central South University, Southwest Hospital, China, First Affiliated Hospital of Xinjiang Medical University, The Second Hospital of Shandong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- Aishan Su, Study director, Nanfang Hospital Guangzhou, Guangdong, China, 510515
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125654
- Sponsor's protocol ID
- 010
- Status last verified
- Aug 2020
- First submitted
- 7 Oct 2019
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases
- ClinicalTrials.gov ID
- NCT04125654
- Acronym / sponsor ID
- 010
- Conditions
- Ascites Infection
- Keywords
- Ascites infection, ascites, mNGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Hospital of Jilin University, Beijing Ditan Hospital, Shanghai Public Health Clinical Center, Taihe Hospital, Xiangya Hospital of Central South University, Southwest Hospital, China, First Affiliated Hospital of Xinjiang Medical University, The Second Hospital of Shandong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, RenJi Hospital
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. Ascites infection including spontaneous bacterial peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared complications of ascites. The EASL guidelines recommend that diagnostic criteria of SBP is defined on the ascitic fluid polymorphonuclear leucocytes (PMN) count ≥250 cell/μl, with or without ascites fluid positive culture. However, in clinical practice. Up to 30% of hospitalized patients are considered as suspicious SBP, and treated as SBP without a laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized patients with ascites. Besides, fungal infection in ascites was aslo related to high mortality in cirrhosis patients.
Thus, to diagnose ascites infection promptly is the key step to prevent the complication. Since, the sensitivity of bacterial culture is limited even if ascites is directly injected into blood culture bottles at the besides. New method to identified the pathogen is needed.
Here, we aim to use metagenomic next-generation sequencing(mNGS) to provide the first-ever demonstration of precision medicine for the diagnosis of ascites infection in hospitalized patients, with immediate impact on clinical care and patients outcomes. The method of mNGS is undertaken by BGI Genomics Company which is a licensed clinical diagnostic laboratory in China. In this multicenter and prospective clinical study, we are planning to detect ascites sample by mNGS and compare the performance of mNGS and routine microbiological testing. Ultimately, we aim to improve the diagnosis of ascites infection and improve patients' outcomes.
Detailed description
The study is divided into 2 parts:
Firstly, the study will test 3 types of sample by means of mNGS, including ascites fluid, peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and specificity of NGS.
Secondly, the clinical validation of mNGS will be performed in multicenters for ascites infection in cirrhosis patients. Furthermore, the study will collect the paired plasma sample for NGS testing at the same time to evaluate the protential sources of microorganisms in ascites.The aim of the study is to observe the performance of mNGS in ascites infection diagosis and the protential clinical effect in cirrhsis patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ascites enrolled for mNGS testing | Experimental | Device: mNGS for pathogen detectionPatients with ascites will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective clinical documents). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalization cirrhotic patients;
- Age >18 years old;
- Paitents with ascites at hospital admission.
Key exclusion criteria (5 listed)
- Pregnant women;
- Hepatic tumor or extrahepatic related cancer;
- Identified secondary peritonitis;
- Ascites not related to portal hypertension;
- Not provide written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGS for pathogen detectionAlso: metagenomic next-generation sequencing testingThis assay is a metagenomic test undertaken by BGI Genomics Co., Ltd. for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples. | Device | Patients with ascites enrolled for mNGS testing |
Primary outcome
Clinical mNGS assay performance (mNGS positive number and the pathogenics species)
Time frame: within 1 month of patient enrollment in study
mNGS positive number and the pathogenics species in ascites
Classification of ascites infection based on mNGS result.
Time frame: within 1 month of patient enrollment in study.
Proportion of spontaneous bacterial peritonitis, bacterascites, neutrocytic ascites and sterile ascites based on mNGS result.
3 secondary outcomes
The proportion of acute kindey injury.
Time frame: within 1 month of patient enrollment in study.
90-day mortality
Time frame: within 90 days of patient enrollment in study
The proportion of new-onset spontaneous bacterial peritonitis.
Time frame: within 1 month of patient enrollment in study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aishan Su study director
Nanfang Hospital Guangzhou, Guangdong, China, 510515
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mNGS for pathogen detection in people with Ascites Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinjun Chen (0086-18588531001, chjj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical mNGS assay performance (mNGS positive number and the pathogenics species) (time frame: within 1 month of patient enrollment in study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.