Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

NCT04320810 | Recruiting

• 1 other identifier: CHFudanU_NNICU13
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Keywords

Metagenome next generation sequencing; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

mNGS diagnosis

Using mNGS to diagnosis infectious disease of this group

Other: no intervention

Interventions

no intervention OTHER

It's only observational study. No interventions.

mNGS diagnosis

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This study mainly focus on the pediatric patients who is suspected of infectious disease.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenhao Zhou, Doctor

  Children's Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

Wenhao Zhou, Doctor

CONTACT

(+86)021-64931003; zwhchfu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: January 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: December 30, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CN (1)