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Status unknownNCT04310657Updated Mar 17, 2020

mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients

An interventional study of mNGS in mNGS, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • mNGS
03

In context

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant and lactating women
  • Who has not signed the informed consent
  • the researchers considered that others were not suitable for the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Precision therapy

    Diagnostic Test: mNGS

  • No intervention
    control

Interventions

  • Diagnostic testmNGS

    Metagenomics second generation sequencing technology

06

What researchers measure

Primary outcomes

  1. 28-day mortality

    28-day mortality

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04310657
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Ruilan Wang (prof, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Mar 17, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Sep 30, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Mar 17, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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