Central Nervous System InfectionsmNGSNCT05887037
Economic Impact of mNGS on Diagnosis of Post-neurosurgical Central Nervous System Infection
A study testing mNGS and The traditional microbiological cultures in people with Central Nervous System Infections, run by Jian-Xin Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Nervous System Infections
- What is being tested?
- mNGS and The traditional microbiological cultures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ·Central nervous system infections
Who cannot join
- Unqualified samples
- Patients and their families refused to sign the informed consent
- The clinician considered the case unsuitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Linlin Zhang
Beijing, Beijing Municipality, 100070
Linlin Zhang, abluelemon@163.com
About this study
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
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.
Read the 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.
- Conditions
- Central Nervous System Infections
- Being tested
- mNGS, The traditional microbiological cultures
- Keywords
- Central nervous system infections, Metagenomic next-generation sequencing
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGSDiagnostic 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
The traditional microbiological culturesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: The traditional microbiological cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost effectiveness ratio
Measures the increased cost for each unit of mortality reduction or increase in cure rate
Measured: up to 12 weeks
Secondary outcomes (2)
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.
Measured: up to 12 weeks
Efficacy comparison
The cure rate and mortality rate of central nervous system infection in the experimental group, and the control group were compared.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2022
- Primary completion20 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887037
- Sponsor's protocol ID
- KY2023-018-02
- Acronym
- mNGS
- Status last verified
- Oct 2023
- First submitted
- 7 May 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05887037
- Acronym / sponsor ID
- mNGS / KY2023-018-02
- Conditions
- Central Nervous System Infections
- Keywords
- Central nervous system infections, Metagenomic next-generation sequencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: mNGS, Diagnostic Test: The traditional microbiological culturesThe 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. |
| Control group | Active comparator | Diagnostic Test: The traditional microbiological culturesAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ·Central nervous system infections
Key exclusion criteria (3 listed)
- Unqualified samples
- Patients and their families refused to sign the informed consent
- The clinician considered the case unsuitable for inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGSmNGS 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 | Diagnostic test | Experimental group |
| The traditional microbiological culturesTraditional 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. | Diagnostic test | Control group, Experimental group |
Primary outcome
Incremental cost effectiveness ratio
Time frame: up to 12 weeks
Measures the increased cost for each unit of mortality reduction or increase in cure rate
2 secondary outcomes
Cost comparison
Time frame: up to 12 weeks
Efficacy comparison
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mNGS and The traditional microbiological cultures in people with Central Nervous System Infections, run by Jian-Xin Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (8610 63926888, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost effectiveness ratio (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.