Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Recruiting

• Conditions: Infectious Disease
• Interventions: Other: no intervention

• Registration Number: NCT04320810
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mNGS diagnosis	no intervention	Using mNGS to diagnosis infectious disease of this group

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China