Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Conditions
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Infectious Disease

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mNGS diagnosis<br>Using mNGS to diagnosis infectious disease of this group | Other: no intervention<br>* It's only observational study. No interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | 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. | From the date of first samples enrolled until the last samples detected, up to 3 years | 
| The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease | 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. | From the date of first samples enrolled until the last samples detected, up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metagenome next generation sequencing, Pediatric