Central Nervous System TuberculosisNCT06011915
A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis
An observational study of Central Nervous System Tuberculosis, run by Tongji Hospital at 2 sites in China.
Trial summary
This is a retrospective clinical study to analyze the clinical characteristics, complications, and effects of different treatment options on long-term prognosis in patients with central nervous system tuberculosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Tuberculosis
- How many people
- 638 participants
- Where
- 2 sitesChina
- Study dates
- 22 Aug 2017to 26 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Central nervous system tuberculosis patients came from Wuhan Pulmonary Hospital, which is a third-class A-level specialized hospital integrating tuberculosis prevention and control, clinical diagnosis and treatment of pulmonary diseases, science, teaching and research, located in Wuhan, Hubei Province, China.
Who may be able to join
- The patient meets the following criteria 1) or 2) or 3):
- The discharge diagnosis is central nervous system tuberculosis, refer to the ICD-10 code related to central nervous system tuberculosis.
- The discharge diagnosis was tuberculous meningitis (ICD-10: A17.000), or tuberculous cerebrospinal meningitis (ICD-10: A17.001), or tuberculous meningoencephalitis (ICD-10: A17.803 ), or tuberculous encephalitis (ICD-10: A17.804), or tuberculous brain abscess (ICD-10: A17.805), or spinal tuberculosis (ICD-10: A17.806), or tuberculous encephalitis Water (ICD-10: A17.807).
- Tuberculous meningitis diagnosed according to the "Guidelines for Diagnosis and Treatment of Central Nervous System Tuberculosis in China (2019 Edition)"
- Age and gender are not limited.
Who cannot join
- Patients with no clear diagnosis at discharge.
- Patients judged by the investigator to be unsuitable for inclusion in this protocol.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)
Hubei, Wuhan, 430030
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
This is a retrospective clinical study to analyze the clinical characteristics, complications, and effects of different treatment options on long-term prognosis in patients with central nervous system tuberculosis. All cases of central nervous system tuberculosis diagnosed between 2016 and 2021 were included in the electronic medical record system of one center, and data such as demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment plans, and outcomes were collected.
- Conditions
- Central Nervous System Tuberculosis
- Medical subject headings
- Tuberculosis, Central Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival rate
Calculate the 1-year survival rate and 2-year survival rate.
Measured: 1 years,2 years
2-year disability rate
Calculate the 1-year disability rate and 2-year disability rate. Common disabilities include aphasia, hemiplegia, paraplegia, deafness, blindness, mental retardation, etc. For reference, please refer to the 《Grading of Human Injury and Disability Degree》 and 《Guidance for determination of cause-and-effect relationship between personal injury and disease》.
Measured: 1 years,2 years
Secondary outcomes (5)
Clinical features: age of onset, mode of onset
age of onset, mode of onset
Measured: 2 years
The presense of clinical symptoms of patients
The number and severity of clinical symptoms of patients.
Measured: 2 years
Incidence of complications in patients with different treatment regimens
The electronic medical record system was used to collect patients' complications from baseline (admission) to 24 months, and the incidence of complications of different treatment options was compared.
Measured: 2 years
length of hospital stay
Measured: 2 years
proportion of patients admitted to ICU
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start22 Aug 2017
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TuberculosisStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Retrospective
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011915
- Sponsor's protocol ID
- RETUBO-N
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis
- ClinicalTrials.gov ID
- NCT06011915
- Acronym / sponsor ID
- RETUBO-N
- Conditions
- Central Nervous System Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 25 Aug 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.
This is a retrospective clinical study to analyze the clinical characteristics, complications, and effects of different treatment options on long-term prognosis in patients with central nervous system tuberculosis. All cases of central nervous system tuberculosis diagnosed between 2016 and 2021 were included in the electronic medical record system of one center, and data such as demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment plans, and outcomes were collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Central nervous system tuberculosis patients came from Wuhan Pulmonary Hospital, which is a third-class A-level specialized hospital integrating tuberculosis prevention and control, clinical diagnosis and treatment of pulmonary diseases, science, teaching and research, located in Wuhan, Hubei Province, China.
Key inclusion criteria (5 listed)
- The patient meets the following criteria 1) or 2) or 3):
- Age and gender are not limited.
Key exclusion criteria (2 listed)
- Patients with no clear diagnosis at discharge.
- Patients judged by the investigator to be unsuitable for inclusion in this protocol.
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
2-year survival rate
Time frame: 1 years,2 years
Calculate the 1-year survival rate and 2-year survival rate.
2-year disability rate
Time frame: 1 years,2 years
Calculate the 1-year disability rate and 2-year disability rate. Common disabilities include aphasia, hemiplegia, paraplegia, deafness, blindness, mental retardation, etc. For reference, please refer to the 《Grading of Human Injury and Disability Degree》 and 《Guidance for determination of cause-and-effect relationship between personal injury and disease》.
5 secondary outcomes
Clinical features: age of onset, mode of onset
Time frame: 2 years
The presense of clinical symptoms of patients
Time frame: 2 years
Incidence of complications in patients with different treatment regimens
Time frame: 2 years
length of hospital stay
Time frame: 2 years
proportion of patients admitted to ICU
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Tuberculosis, run by Tongji Hospital at 2 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival rate (time frame: 1 years,2 years). The study lists 2 primary outcomes in all. 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 28 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.