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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis, Severe

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 Type: Observational
• Enrollment (Anticipated): 86

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with sepsis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 10, 2023
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): June 30, 2025

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (ACTUAL): September 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 20223357008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No