Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Neonatal Sepsis Clinical Trial

Official title:

Assessing the Clinical Value of Metagenomics Sequencing for the Diagnosis and Treatment of Neonatal Sepsis: a Multicenter Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416918
• Other study ID #: CHFudanU_NNICU18
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai

Sponsors (23)

Lead Sponsor

Collaborator

Children's Hospital of Fudan University

Children's Hospital Affiliated to Shandong University, Children's Hospital of Nanjing Medical University, Fujian Provincial Maternity and Children, Gansu Provincial Maternal and Child Health Care Hospital, Henan Maternal and Child Health Care Hospital, Henan Provincial People's Hospital, Hunan Children's Hospital, Jiangxi Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Quanzhou Women's and Children's Hospital, Shengjing Hospital, Shenzhen Maternity and Child Healthcare Hospital, The First Hospital of Jilin University, The Maternal and Child Health Hospital of Guangxi Zhuang autonomous region, Tianjin Central Hospital of Gynecology Obstetrics, Wuhan Children's Hospital, Xiamen Children's Hospital, Xinjiang Children's Hospital, Zhuhai Women and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of metagenomics sequencing	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.	From the date of first samples enrolled until the last samples detected, up to 2 years.
Secondary	Clinical impact of metagenomics sequencing	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.	From the date of first samples enrolled until the last samples detected, up to 2 years.