RecruitingNCT04320810

Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases


Sponsor

Children's Hospital of Fudan University

Enrollment

1,000 participants

Start Date

Jan 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 16 Years

Inclusion Criteria4

  • 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

Exclusion Criteria3

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

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Interventions

OTHERno intervention

It's only observational study. No interventions.


Locations(1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT04320810


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