Application of Next Generation Sequencing Technique in Pediatric Bacterial Meningitis

NCT03953638 | Unknown

• 1 other identifier: 20190514
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Pathogen identification is of paramount importance for bacterial meningitis. At present, the pathogen of bacterial meningitis is still mainly based on Gram stain and bacterial culture. However, cerebrospinal fluid (CSF) culture can be negative in children who receive antibiotic treatment prior to CSF examination.Because of the limitations of clinical laboratory testing, more than half of the central nervous system infection cases cannot be clearly diagnosed. The emergence of powerful next-generation sequencing (NGS) technology have enabled unbiased sequencing of biological samples due to its rapid turnaround time. Previous reports highlight the feasibility of applying NGS of CSF as a diagnostic method for central nervous system (CNS) infection. However, the majority of reports are comprised of single case reports and few studies have been reported in the application of NGS for pathogen detection from CSF samples of bacterial meningitis patients, especially in pediatric populations. In this study, we would like to use the NGS technology to detect directly from the CSF samples of children with bacterial meningitis and evaluate the feasibility and significance of the NGS technique on the pathogenic identification of bacterial meningitis.

Conditions

Next Generation Sequencing; Pediatric Bacterial Meningitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of Pediatric Bacterial Meningitis

  We aim to collect samples cerebrospinal fluid from patients with Pediatric Bacterial Meningitis. Next-generation sequencing will be performed on the collected samples. Our analysis of the sequencing results will focus on the analysis and identification of pathogen genes and will compare the diagnostic performance of next-generation sequencing with conventional etiological diagnostic methods. We anticipate that next-generation sequencing in Pediatric Bacterial Meningitis will show a greater diagnostic value than the traditional methods (including culture, special pathogen antigen, PCR detection of nucleic acids, etc.).

  2 years

Secondary Outcomes (1)

• Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases

  2 years

Interventions

Next Generation Sequencing DIAGNOSTIC_TEST

To provide rapid etiological diagnosis of patients by means of next-generation sequencing.

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients that are highly suspected of bacterial meningitis.

You may qualify if:

• Patients highly suspected of bacterial meningitis

You may not qualify if:

• Non-bacterial infectious central nervous system (CNS) confirmed by viral meningitis, tuberculous meningitis cryptococcal meningitis and so on
• Autoimmune encephalitis cases
• Central nervous system affected by neoplastic disease
• Hemorrhagic cerebrospinal fluid
• Less than 1ml cerebrospinal fluid
• Refusal to enter the group

Sponsors & Collaborators

• Beijing Children's Hospital: lead
• Xingtai People's Hospital: collaborator
• Baoding Children's Hospital: collaborator
• Jinan children's hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Nanjing Children's Hospital: collaborator
• Shenzhen Baoan Maternal and Child Care Service Centre: collaborator
• Jiangxi Children's Hospital: collaborator
• Kunming Children's Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Children's Hospital Affiliated to Suzhou University: collaborator

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal Fluid.

Study Officials

• Gang Liu

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Liu

CONTACT

008613370115008; liugang10@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: February 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: July 31, 2020
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)