Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-12-30

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.

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Detailed Description

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Conditions

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Infectious Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mNGS diagnosis

Using mNGS to diagnosis infectious disease of this group

no intervention

Intervention Type OTHER

It's only observational study. No interventions.

Interventions

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no intervention

It's only observational study. No interventions.

Intervention Type OTHER

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