Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Infectious Disease Clinical Trial

Official title:

Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320810
• Other study ID #: CHFudanU_NNICU13
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Children's Hospital of Fudan University
• Contact: Wenhao Zhou, Doctor
• Phone: (+86)021-64931003
• Email: zwhchfu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Intervention

Other:
• no intervention
It's only observational study. No interventions.

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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