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

Primary Purpose

Central Nervous System Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mNGS
The traditional microbiological cultures
Sponsored by
Jian-Xin Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Nervous System Infections focused on measuring Central nervous system infections, Metagenomic next-generation sequencing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ·Central nervous system infections Exclusion Criteria: Unqualified samples Patients and their families refused to sign the informed consent The clinician considered the case unsuitable for inclusion in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Cost comparison
    The difference in total cost between the mNGS group (experimental group) and the etiology culture group (control group) was compared, and the time cost, detection cost, anti-infection treatment-related cost and other costs were calculated respectively.
    Efficacy comparison
    The cure rate and mortality rate of central nervous system infection in the experimental group, and the control group were compared.

    Full Information

    First Posted
    May 7, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Jian-Xin Zhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887037
    Brief Title
    Economic Impact of mNGS on Diagnosis of Post-neurosurgical Central Nervous System Infection
    Acronym
    mNGS
    Official Title
    Economic Impact of Metagenomic Next-generation Sequencing Versus Traditional Bacterial Culture Directed CNSIs Diagnosis and Therapy in Post-neurosurgical Patients Using a Decision Analysis Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 20, 2025 (Anticipated)
    Study Completion Date
    July 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jian-Xin Zhou

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Central nervous system infections (CNSIs) are severe complications after neurosurgery, that can lead to a poor prognosis. The incidence of postoperative central nervous system infections (PCNSIs) ranges from 2.8% to 14%, and there are differences between different regions. The incidence rate in developed countries is lower than that in developing countries. The most common manifestations of PCNSIs include meningitis, ventriculitis, subdural abscess, epidural abscesses, and brain abscesses. Studies have shown that the most common pathogens of PCNSIs are Staphylococcus aureus, and coagulase-negative staphylococcus, followed by gram-negative bacteria. In China, the pathogen detection rate of traditional cerebrospinal fluid (CSF) culture can only reach 5.4-10%. In addition, culture as the gold standard is time-consuming and susceptible to the use of antibiotics. PCNSIs is related to increased treatment costs, prolonged hospitalization time, psychological trauma and delayed postoperative adjuvant treatment, which places a substantial economic and psychological burden on society and patients' families. Given the seriousness of PCNSIs, it is challenging to choose the appropriate antibiotic treatment for PCNSIs and should be guided by pathogens and their drug sensitivity. Thus, early and efficient diagnosis of pathogens is crucial for PCNSIs. Compared with traditional pathogenic microbial detection methods, metagenomic next-generation sequencing (mNGS) has faster, more accurate, and more complete advantages. Currently, it is widely used in CNSIs, respiratory infections, blood infections, etc., especially suitable for the diagnosis of acute, critical, and complicated infections. Studies have shown that the positive rate of mNGS is much higher than that of culture, and it is less affected by the use of antibiotics, which can provide more accurate feedback on the patient's infection status. At the same time, it can detect a variety of pathogen types, providing more effective guidance for treatment. In addition, the fast detection speed of mNGS can effectively shorten the patient's course of the disease and significantly improve the prognosis of infected patients. Most published mNGS studies are evaluations of their clinical diagnostic value. However, there is still some controversy over the full clinical use of mNGS, and one of the main reasons is cost constraints. The overall cost of mNGS detection reagents and labor in each sample is much higher than that of traditional detection methods. There are still no reports on health economics research on the use of mNGS to diagnose CNSIs after neurosurgery. Therefore, prospective clinical trials are needed to evaluate the cost-effectiveness of mNGS, a relatively expensive new detection method. In summary, this study intends to conduct a health economics study of mNGS to diagnose postoperative central nervous system infections and evaluate whether mNGS, as a relatively expensive new technology, can identify the pathogen at the early stage, shorten the time of anti-infective treatment, reduce the overall medical cost, and improve the cure rate of patients. In addition, this study provides theoretical guidance for clinical and public health departments to make cost-effective decisions more scientifically, make more effective use of medical resources, and improve the social and economic benefits of etiological diagnosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Nervous System Infections
    Keywords
    Central nervous system infections, Metagenomic next-generation sequencing

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    204 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    mNGS
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    The traditional microbiological cultures
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incremental cost effectiveness ratio
    Description
    Measures the increased cost for each unit of mortality reduction or increase in cure rate
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Cost comparison
    Description
    The difference in total cost between the mNGS group (experimental group) and the etiology culture group (control group) was compared, and the time cost, detection cost, anti-infection treatment-related cost and other costs were calculated respectively.
    Time Frame
    up to 12 weeks
    Title
    Efficacy comparison
    Description
    The cure rate and mortality rate of central nervous system infection in the experimental group, and the control group were compared.
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ·Central nervous system infections Exclusion Criteria: Unqualified samples Patients and their families refused to sign the informed consent The clinician considered the case unsuitable for inclusion in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jian-Xin Zhou, MD
    Phone
    8610 63926888
    Email
    zhoujx.cn@icloud.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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