Infectious Disease
Conditions
Keywords
Metagenome next generation sequencing, Pediatric
Brief 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.
Interventions
OTHERno intervention
It's only observational study. No interventions.
Sponsors
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Congenital malformations； * Patients requiring surgical intervention; * Patients with skin barrier dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | From the date of first samples enrolled until the last samples detected, up to 3 years | Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods. |
| The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | From the date of first samples enrolled until the last samples detected, up to 3 years | Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods. |
Countries
China
Contacts
Primary ContactWenhao Zhou, Doctor
Outcome results
None listed