NCT04310657

Brief Summary

1\) prospectively collected the patients with the proposed infection, confirmed the infection or excluded the infection through mNGS detection combined with traditional pathogen detection methods and clinical characteristics, compared the detection performance of mNGS and traditional methods, and explored the significance of mNGS microbial map characteristics for the diagnosis/exclusion of infection; 2) real-time dynamic monitoring of the pathogen and microecology of infected patients during the targeted drug use, and evaluation of the efficacy in combination with other indicators; 3) to explore the significance of the number of pathogen sequences before the clinical withdrawal of drugs to the clinical practice.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

March 13, 2020

Last Update Submit

March 16, 2020

Conditions

mNGS

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    28-day mortality

    28 days

Study Arms (2)

Precision therapy

EXPERIMENTAL
Diagnostic Test: mNGS

control

NO INTERVENTION

Interventions

mNGSDIAGNOSTIC_TEST

Metagenomics second generation sequencing technology

Precision therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years old
  • expected length of stay in ICU was \> 24 h
  • suspected infected patients (PSI or CPIS, qSOFA or SIRS)

You may not qualify if:

  • Pregnant and lactating women
  • Who has not signed the informed consent
  • the researchers considered that others were not suitable for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 17, 2020

Record last verified: 2020-03