SepsisNCT03760315
mNGS vs Culture Critically Ill Patients
An observational study of Sepsis, run by Southeast University, China at 1 site in China.
Trial summary
mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- blood mNGS (IDSeqTM Ultra); blood Culture
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Dec 2022
- Phase
- Observational
- 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
Study population: Patient with sepsis and suspected bloodstream infection
Who may be able to join
- Age > 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;
Who cannot join
- Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, 210009
Ling Liu, MD., 86-25-83272201, liulingdoctor@126.com
Haibo Qiu, PhD.,MD., 86-25-83272200, haiboq2000@yahoo.com.cn
About this study
Official title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.
Read the detailed description
Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.
- Conditions
- Sepsis
- Being tested
- blood mNGS (IDSeqTM Ultra); blood Culture
- Keywords
- next- generation sequencing； blood culture；IDSeqTM Ultra
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood mNGS (IDSeqTM Ultra); blood CultureDiagnostic test
take blood samples for mNGS and Culture at the same time in sepsis patients. No intervention on the treatment of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | All enrolled patients Receives: Diagnostic Test: blood mNGS (IDSeqTM Ultra); blood Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of positive rate between mNGS and Culture
The difference between the positive rate of mNGS and the positive rate of blood culture.
Measured: 28 day
Secondary outcomes (5)
The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact
Positive, Negative，None and Indeterminate
Measured: 28 day
Change of SOFA
change of SOFA score (include each organ) at baseline, day 3 and day 7 clinical improvement :Improvement in 2 or more clinical signs and symptoms no requirement for additional antibacterial treatment Clinical failure:Persistence or progression of baseline signs and symptoms
Measured: 7 day
Mortality
28 day，ICU and hospital mortality Documented microbiologic eradication:Absence of primary microbe from infection site Presumed microbiologic eradication:Clinical cure without available microbiologic culture data Presumed microbiologic persistence:Clinical failure in the absence of any microbiologic data Documented microbiologic persistence:Continued presence of MRSA based on microbiologic culture Superinfection: Clinical failure and isolation of a pathogen not present at baseline at the original infection site
Measured: During hospitalization
Length of stay
ICU and hospital length of stay
Measured: During hospitalization
Anti-infective treatment adjustment
each Anti-infective treatment adjustment
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Apr 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu People's Hospital
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Haibo Qiu, MD, Study director, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760315
- Sponsor's protocol ID
- 20181127
- Status last verified
- Aug 2022
- First submitted
- 28 Nov 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Q, Teng R, Shi Q, Liu Y, Cai X, Yang B, Cao Q, Shu C, Mei X, Zeng W, Hu B, Zhang J, Qiu H, Liu L. Clinical implement of Probe-Capture Metagenomics in sepsis patients: A multicentre and prospective study. Clin Transl Med. 2025 Apr;15(4):e70297. doi: 10.1002/ctm2.70297.
PubMed 40181528
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
- ClinicalTrials.gov ID
- NCT03760315
- Acronym / sponsor ID
- 20181127
- Conditions
- Sepsis
- Keywords
- next- generation sequencing； blood culture；IDSeqTM Ultra
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu People's Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Nov 2018 (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.
mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.
Detailed description
Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Diagnostic Test: blood mNGS (IDSeqTM Ultra); blood CultureAll enrolled patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with sepsis and suspected bloodstream infection
Key inclusion criteria (1 listed)
- Age > 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;
Key exclusion criteria (1 listed)
- Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;
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 |
|---|---|---|
| blood mNGS (IDSeqTM Ultra); blood Culturetake blood samples for mNGS and Culture at the same time in sepsis patients. No intervention on the treatment of the patients. | Diagnostic test | Sepsis |
Primary outcome
difference of positive rate between mNGS and Culture
Time frame: 28 day
The difference between the positive rate of mNGS and the positive rate of blood culture.
5 secondary outcomes
The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact
Time frame: 28 day
Change of SOFA
Time frame: 7 day
Mortality
Time frame: During hospitalization
Length of stay
Time frame: During hospitalization
Anti-infective treatment adjustment
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 40181528Sun Q, Teng R, Shi Q, Liu Y, Cai X, Yang B, Cao Q, Shu C, Mei X, Zeng W, Hu B, Zhang J, Qiu H, Liu L. Clinical implement of Probe-Capture Metagenomics in sepsis patients: A multicentre and prospective study. Clin Transl Med. 2025 Apr;15(4):e70297. doi: 10.1002/ctm2.70297.
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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.
Haibo Qiu, MD study director
Southeast University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Southeast University, China 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 1 inclusion and 1 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 5 Aug 2022. 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 ling liu, MD (13851435472, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of positive rate between mNGS and Culture (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760315, which also lists 1 linked publication.
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 5 Aug 2022.