EncephalitisNCT04946682
Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
A study testing Types of etiological diagnostic methods in people with Encephalitis and Meningitis, run by Wen-hong Zhang at 7 sites in China.
Trial summary
Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Encephalitis, Meningitis, Meningoencephalitis
- What is being tested?
- Types of etiological diagnostic methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 7 sitesChina
- Study dates
- 14 Apr 2021to 30 Apr 2023
- 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
- Patients with suspected meningitis : the patient has a new fever (>38.5℃), accompanied by ≥1 of the following manifestations：
- Stiff neck
- Change in state of consciousness
- Other signs of meningitis: such as meningeal irritation.
- Patients with suspected encephalitis: Unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations:
- Fever during the course of the disease (≥ 38℃); (oral temperature)
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- Convulsions or focal neurological symptoms;
- Increase in the number of cerebrospinal fluid cells (>4*10^6/L);
- Abnormal EEG that meets the manifestations of encephalitis and cannot be attributed to other reasons
- Imaging suggests encephalitis (CT or MRI)
- Have not received effective anti-infective treatment yet
- Have an identifiable address and live in the area during treatment.
- Suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required).
- Willing to comply with follow-up research procedures.
Who cannot join
- Known breastfeeding or pregnancy
- Failure to comply with treatment or follow-up time;
- The researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe;
- Participating in other clinical studies
- Insufficient cerebrospinal fluid or blood samples
- Clinically diagnosed infections, tumors or other neurological diseases
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210001
Yanliang Zhang, 13815440366, swinburn@163.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Li Cai, 18817821207, lilytsai1990@163.com
- Recruiting
Shanghai Blue Cross Brain Hospital
Shanghai, Shanghai Municipality, 201101
Jinghua Ye, 15316925807, 1271648050@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Yanlin Zhang, 13771710630, zhangyanlin0012006@163.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tingting Feng, 13771815873, fengting3@163.com
- Not yet recruiting
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, 214016
Renfang Chen, 13621519216
- Not yet recruiting
People's Hospital of Zhuji, Zhejiang Province
Zhuji, Zhejiang, 311899
Heqing Huang, 13858516315, zjganran@163.com
About this study
Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. It was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. As such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.
- Conditions
- Encephalitis, Meningitis, Meningoencephalitis, Next-Generation Sequencing, Polymerase Chain Reaction
- Being tested
- Types of etiological diagnostic methods
- Medical subject headings
- Encephalitis, Meningitis, Meningoencephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types of etiological diagnostic methodsDiagnostic test
In Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group of mNGS | Experimental | Not described Receives: Diagnostic Test: Types of etiological diagnostic methods |
| Group of PCR | Experimental | Not described Receives: Diagnostic Test: Types of etiological diagnostic methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change Modified Rankin Scale (mRS) at 1 year
The Modified Rankin Scale at 1 year Grade Description 0 No symptoms
- Minor symptoms not interfering with lifestyle
- Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves
- Symptoms that restrict lifestyle and prevent totally independent living
- Symptoms that clearly prevent independent living, although the patient does not need constant care and attention
- Totally dependent, requiring constant help day and night
Measured: mRS should be measured at 1 year
Secondary outcomes (1)
Mortality rate at 1 year
Mortality rate at 1 year
Measured: Mortality rate at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start14 Apr 2021
- Primary completion14 Apr 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EncephalitisStudies 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
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-hong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946682
- Sponsor's protocol ID
- IMPROVE
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Zhang H, Deng B, Lin K, Jin L, Liu X, Zhang Y, Chen X, Zhang Y, Lu S, Huang H, Wang Q, Feng T, Zhao W, Xue Q, Chen R, Zhang J, Qian X, Chen L, Ai J, Chen X, Zhang W. Optimal encephalitis/meningitis roadmap via precise diagnosis and treatment (IMPROVE): a study protocol for a randomized controlled trial. BMC Infect Dis. 2022 Jan 8;22(1):40. doi: 10.1186/s12879-021-06943-6.
PubMed 34998377
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT04946682
- Acronym / sponsor ID
- IMPROVE
- Conditions
- Encephalitis, Meningitis, Meningoencephalitis, Next-Generation Sequencing, Polymerase Chain Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Wen-hong ZhangUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 14 Apr 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 1 Jul 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.
Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. It was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. As such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of mNGS | Experimental | Diagnostic Test: Types of etiological diagnostic methods |
| Group of PCR | Experimental | Diagnostic Test: Types of etiological diagnostic methods |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with suspected meningitis : the patient has a new fever (>38.5℃), accompanied by ≥1 of the following manifestations：
- Patients with suspected encephalitis: Unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations:
- Have not received effective anti-infective treatment yet
- Have an identifiable address and live in the area during treatment.
- Suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required).
Key exclusion criteria (6 listed)
- Known breastfeeding or pregnancy
- Failure to comply with treatment or follow-up time;
- The researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe;
- Participating in other clinical studies
- Insufficient cerebrospinal fluid or blood samples
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 |
|---|---|---|
| Types of etiological diagnostic methodsIn Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines. | Diagnostic test | Group of PCR, Group of mNGS |
Primary outcome
The change Modified Rankin Scale (mRS) at 1 year
Time frame: mRS should be measured at 1 year
The Modified Rankin Scale at 1 year Grade Description 0 No symptoms 1. Minor symptoms not interfering with lifestyle 2. Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves 3. Symptoms that restrict lifestyle and prevent totally independent living 4. Symptoms that clearly prevent independent living, although the patient does not need constant care and attention 5. Totally dependent, requiring constant help day and night
1 secondary outcome
Mortality rate at 1 year
Time frame: Mortality rate at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 34998377Zhang Y, Zhang H, Deng B, Lin K, Jin L, Liu X, Zhang Y, Chen X, Zhang Y, Lu S, Huang H, Wang Q, Feng T, Zhao W, Xue Q, Chen R, Zhang J, Qian X, Chen L, Ai J, Chen X, Zhang W. Optimal encephalitis/meningitis roadmap via precise diagnosis and treatment (IMPROVE): a study protocol for a randomized controlled trial. BMC Infect Dis. 2022 Jan 8;22(1):40. doi: 10.1186/s12879-021-06943-6.
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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.
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Types of etiological diagnostic methods in people with Encephalitis and Meningitis, run by Wen-hong Zhang at 7 sites 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 14 inclusion and 6 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 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change Modified Rankin Scale (mRS) at 1 year (time frame: mRS should be measured at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946682, which also lists 1 linked publication.
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 1 Jul 2021.