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临床试验/NCT05887037
NCT05887037招募中不适用

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

Jian-Xin Zhou1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
204
试验地点
1
主要终点
Incremental cost effectiveness ratio

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •·Central nervous system infections

排除标准

  • •Unqualified samples
  • •Patients and their families refused to sign the informed consent
  • •The clinician considered the case unsuitable for inclusion in the study

研究组 & 干预措施

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.

干预措施: mNGS (Diagnostic Test)

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.

干预措施: The traditional microbiological cultures (Diagnostic Test)

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.

干预措施: The traditional microbiological cultures (Diagnostic Test)

结局指标

主要结局

Incremental cost effectiveness ratio

时间窗: up to 12 weeks

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

次要结局

  • Cost comparison(up to 12 weeks)
  • Efficacy comparison(up to 12 weeks)

研究者

发起方
Jian-Xin Zhou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jian-Xin Zhou

Professor

Capital Medical University

研究点 (1)

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