Actively Recruiting

Age: 0 - 16Years
All Genders
NCT04320810

Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Led by Children's Hospital of Fudan University · Updated on 2024-05-13

1000

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.

CONDITIONS

Official Title

Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Who Can Participate

Age: 0 - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients are highly suspected of sepsis
  • Patients are highly suspected of respiratory infections
  • Patients are highly suspected of central nervous system infection
  • Patients are highly suspected of fever of unknown origin
Not Eligible

You will not qualify if you...

  • Congenital malformations
  • Patients requiring surgical intervention
  • Patients with skin barrier dysfunction

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

W

Wenhao Zhou, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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