Sepsis, SevereNCT05540808
The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
An observational study of Sepsis, Severe, run by Shenzhen Second People's Hospital.
Trial summary
The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2023to 30 Jun 2025
- 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: patients with sepsis
Who may be able to join
- Critical care patients aged ≥ 18 years old
- Patients with sepsis
Who cannot join
- Lack of traditional pathogen detection results
- Discharge diagnosis without clear etiology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.
Read the detailed description
This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.
- Conditions
- Sepsis, Severe
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
The chance of testing positive for a pathogen in a sample judged by the gold standard
Measured: up to 3 year
specificity
The chance of a negative test in a sample judged pathogen-free by the gold standard
Measured: up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start10 Feb 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, SevereStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Li, Study chair, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540808
- Sponsor's protocol ID
- 20223357008
- Status last verified
- Jul 2022
- First submitted
- 13 Sep 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
- ClinicalTrials.gov ID
- NCT05540808
- Acronym / sponsor ID
- 20223357008
- Conditions
- Sepsis, Severe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 10 Feb 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Sep 2022 (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.
The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.
Detailed description
This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sepsis
Key inclusion criteria (2 listed)
- Critical care patients aged ≥ 18 years old
- Patients with sepsis
Key exclusion criteria (2 listed)
- Lack of traditional pathogen detection results
- Discharge diagnosis without clear etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity
Time frame: up to 3 year
The chance of testing positive for a pathogen in a sample judged by the gold standard
specificity
Time frame: up to 3 year
The chance of a negative test in a sample judged pathogen-free by the gold standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Ying Li study chair
Shenzhen Second People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Severe, run by Shenzhen Second People's Hospital.
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 2 inclusion and 2 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ni Xie (0755-83366388, zengzhuoying@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: up to 3 year). 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 6 Feb 2023.