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NCT05540808 Clinical Trial

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

Sepsis, Severe Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05540808
Other study ID # 20223357008
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 10, 2023
Est. completion date June 30, 2025

Study information
Verified date July 2022
Source Shenzhen Second People's Hospital
Contact Ni Xie
Phone 0755-83366388
Email zengzhuoying@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 86
Est. completion date June 30, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shenzhen Second People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity The chance of testing positive for a pathogen in a sample judged by the gold standard up to 3 year
Primary specificity The chance of a negative test in a sample judged pathogen-free by the gold standard up to 3 year
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