Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Fudan University

Status: Enrolling

Conditions: Infectious Disease

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04320810

CHFudanU_NNICU13

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

mNGS diagnosis

Description:

Using mNGS to diagnosis infectious disease of this group

Treatment:

Other: no intervention