Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Completed

• Conditions: Neonatal Sepsis

• Registration Number: NCT05416918
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. These patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.

Detailed Description

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. As a multi-center prospective observational clinical study, the study intends to enroll 2000 suspected neonatal sepsis cases from multiple centers. Culture, classical PCR and mNGS were performed simultaneously. This study is one of the few multi-center studies in China to evaluate the value of mNGS in the diagnosis and treatment of neonatal sepsis, and will provide representative data for the distribution characteristics of pathogen spectrum of children in the real world and the clinical diagnosis and treatment value of mNGS.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-14
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Neonates with suspected early-onset sepsis or late-onset sepsis;
• Neonates diagnosed with clinical sepsis.

Exclusion Criteria

• Died before the results of conventional methods test or metagenomics test were obtained;
• Suffering from diseases of the blood system;
• Suffering from malignant tumor;
• Birth defects, congenital heart disease or autoimmune disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of metagenomics sequencing	From the date of first samples enrolled until the last samples detected, up to 2 years.	The diagnostic performance of metagenomics sequencing for neonatal sepsis was evaluated by calculating sensitivity and specificity. Sensitivity = mNGS positive samples/ reference standard methods positive samples; Specificity = mNGS negative samples/ reference standard methods negative samples.

Secondary Outcome Measures

Name	Time	Method
Clinical impact of metagenomics sequencing	From the date of first samples enrolled until the last samples detected, up to 2 years.	Clinical impact of metagenomics sequencing was evaluated by calculating the positive impact rate, negative impact rate and no impact rate. Positive impact rate = positive impact cases/ total cases; negative impact rate = negative impact cases/ total cases; no impact rate = no impact cases/ total cases. Clinical impact was assessed according to predefined objective grading criteria.

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, China