Central Nervous System Infections and InflammationsMEMBERNCT04724876
Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research
An observational study of Central Nervous System Infections and Inflammations, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Autoimmune encephalitis (AE) is caused by abnormal immune response mediated by autoimmune antibodies of patients, which can be detected by a serial of autoimmune antibodies[4,5,6,7]. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Central Nervous System Infections and Inflammations
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to Jun 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected central nervous system infection.
Who may be able to join
- Either meet the items of 1, 2 or 1, 3
- The patient's age >14 years old, acute or subacute onset (less than 3 months), (first onset, treatment with anti-infection drugs and/or immunotherapy ≤5 days);
- The patient has the following symptoms:
- Dysmnesia,
- Seizures,
- Mental disorders,
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- Abnormal behavior,
- Unconsciousness or coma,
- Dyskinesia or involuntary movement,
- lalopathy or be reticent,
- Dysphagia, sleep disorders, or autonomic nervous dysfunction,
- Ataxia.
- Patients with meningeal irritation sign, intracranial hypertension and other manifestations, satisfy at least 3 of the following symptoms:
- Headache,
- Fever,
- Stiff neck,
- Disturbance of consciousness,
- Kernig sign or brudzinski sign was positive.
Who cannot join
- 1. Patients with suspected metabolic encephalopathy and toxic encephalopathy have the above manifestations,
- 2. Patients with central nervous system tumor (primary or metastatic) have the above manifestations,
- 3. The patient with non-organic mental illness,
- 4. Patients who had undergone brain surgery within 6 months have the above symptoms after operation,
- 5. Patients with traumatic brain injury have the above manifestations,
- 6. Febrile convulsions caused by non-cerebral causes,
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- 7. Patients with above manifestations due to other reasons such as cerebrovascular disease, genetic disease, etc;
- 8. Patients who refuse lumbar puncture or have contraindications to lumbar puncture;
- 9. Patients who withdraw informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, 100730
Jiawei Wang, doctor, 18811612263, pengyujing1206@163.com
About this study
Official title: Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research (MEMBER Research)
Autoimmune encephalitis (AE) is caused by abnormal immune response mediated by autoimmune antibodies of patients, which can be detected by a serial of autoimmune antibodies[4,5,6,7]. At present, the traditional infection diagnosis mainly relies on microbial culture method, which has the characteristics of long cycle, high cost, low detection rate and complex detection process. About 30-60% of encephalitis have unknown etiology[2,3]. On the other hand, the diagnosis and classification of noninfectious encephalitis mainly depend on the detection of autoimmune antibodies, the scope of diagnosis and differential diagnosis is limited, and the relationship between autoimmune encephalitis and infection factors is still unclear. Metagenomics sequencing (mNGS) is a new method that does not rely on microbial culture and can directly detect pathogenic nucleic acids. It has the characteristics of fast, accurate, high throughput, no preference for different pathogen detection, and can detect known and unknown pathogens at the same time. Nowadays, mNGS is widely used in the field of pathogen detection.
- Medical subject headings
- Central Nervous System Infections, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
To elucidate the etiology and epidemiology of CNS infection all around China
The Investigators use mNGS method to describe central nervous system infection spectrum.
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start31 Dec 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (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 Infections and InflammationsStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Air Force Military Medical University, China, Peking Union Medical College Hospital, The Second Hospital of Hebei Medical University, First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Xuanwu Hospital, Beijing, Third Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital, Fudan University, West China Hospital, Henan Provincial People's Hospital, Central South University, The First Affiliated Hospital of Shanxi Medical University
- Responsible party
- Principal investigator, Jia Wei Wang,MD,PhD, Beijing Tongren Hospital
- Investigators
- Jiawei Wang, Doctor, Principal investigator, Beijing Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724876
- Sponsor's protocol ID
- TRECKY2020-141
- Acronym
- MEMBER
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research (MEMBER Research)
- ClinicalTrials.gov ID
- NCT04724876
- Acronym / sponsor ID
- MEMBER / TRECKY2020-141
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Air Force Military Medical University, China, Peking Union Medical College Hospital, The Second Hospital of Hebei Medical University, First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Xuanwu Hospital, Beijing, Third Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital, Fudan University, West China Hospital, Henan Provincial People's Hospital, Central South University, The First Affiliated Hospital of Shanxi Medical University
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Jan 2021 (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.
Autoimmune encephalitis (AE) is caused by abnormal immune response mediated by autoimmune antibodies of patients, which can be detected by a serial of autoimmune antibodies[4,5,6,7]. At present, the traditional infection diagnosis mainly relies on microbial culture method, which has the characteristics of long cycle, high cost, low detection rate and complex detection process. About 30-60% of encephalitis have unknown etiology[2,3]. On the other hand, the diagnosis and classification of noninfectious encephalitis mainly depend on the detection of autoimmune antibodies, the scope of diagnosis and differential diagnosis is limited, and the relationship between autoimmune encephalitis and infection factors is still unclear. Metagenomics sequencing (mNGS) is a new method that does not rely on microbial culture and can directly detect pathogenic nucleic acids. It has the characteristics of fast, accurate, high throughput, no preference for different pathogen detection, and can detect known and unknown pathogens at the same time. Nowadays, mNGS is widely used in the field of pathogen detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected central nervous system infection.
Key inclusion criteria (18 listed)
- Either meet the items of 1, 2 or 1, 3
Key exclusion criteria (9 listed)
- 1. Patients with suspected metabolic encephalopathy and toxic encephalopathy have the above manifestations,
- 2. Patients with central nervous system tumor (primary or metastatic) have the above manifestations,
- 3. The patient with non-organic mental illness,
- 4. Patients who had undergone brain surgery within 6 months have the above symptoms after operation,
- 5. Patients with traumatic brain injury have the above manifestations,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To elucidate the etiology and epidemiology of CNS infection all around China
Time frame: within 2 weeks
The Investigators use mNGS method to describe central nervous system infection spectrum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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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.
Jiawei Wang, Doctor principal investigator
Beijing Tong Ren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Infections and Inflammations, run by Beijing Tongren Hospital 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 18 inclusion and 9 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 26 Jan 2021. 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 Jiawei Wang, Doctor (18811612263, pengyujing1206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To elucidate the etiology and epidemiology of CNS infection all around China (time frame: within 2 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 26 Jan 2021.