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

Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05540808
Enrollment
86
Registered
2022-09-15
Start date
2023-02-10
Completion date
2025-06-30
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Severe

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.

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.

Interventions

None listed

Sponsors

Shenzhen Second People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
sensitivityup to 3 yearThe chance of testing positive for a pathogen in a sample judged by the gold standard
specificityup to 3 yearThe chance of a negative test in a sample judged pathogen-free by the gold standard

Contacts

Primary ContactNi Xie
zengzhuoying@qq.com0755-83366388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026