NCT05540808

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 6, 2023

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

September 13, 2022

Last Update Submit

February 3, 2023

Conditions

Sepsis, Severe

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with sepsis

You may qualify if:

  • Critical care patients aged ≥ 18 years old
  • Patients with sepsis

You may not qualify if:

  • Lack of traditional pathogen detection results
  • Discharge diagnosis without clear etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ying Li

    Shenzhen Second People's Hospital

    STUDY CHAIR

Central Study Contacts

Ni Xie

CONTACT

0755-83366388zengzhuoying@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

February 10, 2023

Primary Completion

July 31, 2024

Study Completion

June 30, 2025

Last Updated

February 6, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share