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The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540808
Collaborator
(none)
86
Enrollment
33.6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    86 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
    Anticipated Study Start Date :
    Sep 10, 2022
    Anticipated Primary Completion Date :
    Jul 31, 2024
    Anticipated Study Completion Date :
    Jun 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. sensitivity [up to 3 year]

      The chance of testing positive for a pathogen in a sample judged by the gold standard

    2. specificity [up to 3 year]

      The chance of a negative test in a sample judged pathogen-free by the gold standard

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Critical care patients aged ≥ 18 years old

    • Patients with sepsis

    Exclusion Criteria:

    • Lack of traditional pathogen detection results

    • Discharge diagnosis without clear etiology

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shenzhen Second People's Hospital

    Investigators

    • Study Chair: Ying Li, Shenzhen Second People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen Second People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05540808
    Other Study ID Numbers:
    • 20223357008
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Sep 15, 2022