Economic Impact of mNGS on Diagnosis of Post-neurosurgical Central Nervous System Infection

NCT05887037 | Unknown DMC

• 1 other identifier: KY2023-018-02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study was to assess the economic impact of using metagenomic next-generation sequencing (mNGS) versus traditional bacterial culture directed CNSIs diagnosis and therapy in post-neurosurgical patients from Beijing Tiantan Hospital. mNGS is a relatively expensive test item, and whether it has the corresponding health economic significance in the clinical application of diagnosing intracranial infection has not been studied clearly. Therefore, the investigators hope to explore the clinical application value of mNGS detection in central nervous system infection after neurosurgery.

Conditions

Central Nervous System Infections

Keywords

Central nervous system infections; Metagenomic next-generation sequencing

Outcome Measures

Primary Outcomes (1)

• Incremental cost effectiveness ratio

  Measures the increased cost for each unit of mortality reduction or increase in cure rate

  up to 12 weeks

Secondary Outcomes (2)

• Cost comparison

  up to 12 weeks

• Efficacy comparison

  up to 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group was sent for CSF mNGS and traditional microbiological cultures at the same time, and the mNGS results were usually earlier than the traditional microbiological cultures results. The experimental group adjusted or continued the current medication regimen according to the mNGS reporting pathogen and the expert team's opinion. Subsequently, if the CSF traditional microbiological cultures results in the experimental group are consistent with the mNGS results, the current treatment plan of the patient is continued, and if the results are inconsistent with the mNGS results, the expert team needs to discuss and adjust the treatment plan. When no causative organism is detected in mNGS, empiric treatment is continued, and treatment is adjusted pending the pathogen culture results.

Diagnostic Test: mNGS; Diagnostic Test: The traditional microbiological cultures

Control group

ACTIVE COMPARATOR

After a clinical diagnosis of central nervous system infection, the control group was treated empirically based on only cerebrospinal fluid for traditional microbiological cultures, without mNGS detection, and the treatment plan was adjusted according to the traditional microbiological cultures results. If the patient's culture is negative and empiric therapy does not improve, cerebrospinal fluid is retained for mNGS testing. Treatment is adjusted based on mNGS results and expert team evaluation.

Diagnostic Test: The traditional microbiological cultures

Interventions

mNGS DIAGNOSTIC_TEST

mNGS is the direct extraction of nucleic acid from clinical samples. High-throughput sequencing technology and bioinformatics analysis were adopted to complete the detection of pathogens such as bacteria, fungi, viruses and parasites at one time

Experimental group

The traditional microbiological cultures DIAGNOSTIC_TEST

Traditional microbial culture is the gold standard for the diagnosis of central nervous system infection, but the traditional microbiological culture time is long and the detection rate is low.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ·Central nervous system infections

You may not qualify if:

• Unqualified samples
• Patients and their families refused to sign the informed consent

Sponsors & Collaborators

• Jian-Xin Zhou: lead

Study Sites (1)

Linlin Zhang

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Central Nervous System Infections

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 63926888; zhoujx.cn@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 2, 2023
• Study Start: July 1, 2022
• Primary Completion: June 20, 2025
• Study Completion: July 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)