Tuberculous MeningitisNCT06811792
Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes
An observational study of Tuberculous Meningitis, run by Beijing Chest Hospital.
Trial summary
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis (TB). While anti-TB regimens remain the cornerstone of treatment, spinal injection of dexamethasone is considered a potentially effective adjuvant therapy. However, its impact on mortality and disability remains uncertain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculous Meningitis
- What is being tested?
- Intrathecal Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 837 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2024
- How long will I take part?
- 12 Months
- 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: Treatment Interventions Patients who underwent at least one lumbar puncture and spinal canal administration of glucocorticoids during hospitalisation were classified as receiving intrathecal (IT) therapy. Dexamethasone was the glucocorticoid administered intrathecally at a dose of 5 mg per administration. All patients also received oral or intravenous anti-TB regimens, which included at least isoniazid and rifampicin for drug-sensitive TBM cases. Patients diagnosed with or suspected of having drug-resistant TBM who required second-line anti-TB drugs were excluded from the study.
Who may be able to join
- 1. A positive pathogenic diagnosis of tuberculous meningitis, or clinical diagnosis of tuberculous meningitis, refer to the 《2019 Chinese guidelines for the diagnosis and treatment of central nervous system tuberculosis》; 2. Complete patient information can be found, included patients' demographic characteristics, medical histories, presenting signs and symptoms, clinical course, laboratory test results, diagnostic studies, treatments, complications; 3. Patients can be collected from the time of diagnosis and medication to 12 months.
Who cannot join
- 1. HIV positive patients (as HIV positive patients in China require diagnosis and treatment in specific healthcare systems); 2. Patients who are unable to collect complete demographic information, diagnostic and treatment information, or treatment outcomes.
About this study
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis (TB). While anti-TB regimens remain the cornerstone of treatment, spinal injection of dexamethasone is considered a potentially effective adjuvant therapy. However, its impact on mortality and disability remains uncertain. This study analysed all TBM patients admitted to Beijing Chest Hospital affiliated with Capital Medical University from January 1, 2010 to December 31, 2023. Patients were categorised into two groups based on whether they received standard anti-TB therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-TB therapy alone (non-intrathecal therapy group). Propensity score matching was used to balance baseline characteristics, and one-year mortality and severe disability rates were statistically compared between the groups.
- Conditions
- Tuberculous Meningitis
- Being tested
- Intrathecal Therapy
- Keywords
- Intrathecal Therapy, Tuberculous Meningitis, Outcome
- Medical subject headings
- Tuberculosis, Meningeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal TherapyProcedure or surgery
Patients who underwent at least one lumbar puncture and spinal canal administration of glucocorticoids during hospitalisation were classified as receiving intrathecal (IT) therapy. Dexamethasone was the glucocorticoid administered intrathecally at a dose of 5 mg per administration. All patients also received oral or intravenous anti-TB regimens, which included at least isoniazid and rifampicin for drug-sensitive TBM cases. Patients diagnosed with or suspected of having drug-resistant TBM who required second-line anti-TB drugs were excluded from the study.
| Study group | Role | What they receive |
|---|---|---|
| central nervous system tuberculosis | central nervous system tuberculosis (CNS TB) was confirmed by positive results from traditional microbiological tests or nucleic acid amplification testing for Mycobacterium tuberculosis. Patients without microbiological confirmation were diagnosed based on clinical manifestations. Patients were categorised into two groups based on whether they received standard anti-TB therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-TB therapy alone (non-intrathecal therapy group). Receives: Procedure: Intrathecal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality within 12 months of treatment initiation
The primary endpoint was all-cause mortality within 12 months of treatment initiation.
Measured: From clear diagnosis to the following 12 months.
Secondary outcomes (1)
Disability rate
The disability rate of tuberculosis meningitis patients within 12 months after diagnosis and treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculous MeningitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 837 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie WenJuan, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811792
- Sponsor's protocol ID
- GCP-TB-2024-9-30
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have a requirement that hospital information and patient information cannot be shared casually.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06811792
- Acronym / sponsor ID
- GCP-TB-2024-9-30
- Conditions
- Tuberculous Meningitis
- Keywords
- Intrathecal Therapy, Tuberculous Meningitis, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 837 participants (actual)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Feb 2025 (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.
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis (TB). While anti-TB regimens remain the cornerstone of treatment, spinal injection of dexamethasone is considered a potentially effective adjuvant therapy. However, its impact on mortality and disability remains uncertain. This study analysed all TBM patients admitted to Beijing Chest Hospital affiliated with Capital Medical University from January 1, 2010 to December 31, 2023. Patients were categorised into two groups based on whether they received standard anti-TB therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-TB therapy alone (non-intrathecal therapy group). Propensity score matching was used to balance baseline characteristics, and one-year mortality and severe disability rates were statistically compared between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| central nervous system tuberculosis | – | Procedure: Intrathecal Therapycentral nervous system tuberculosis (CNS TB) was confirmed by positive results from traditional microbiological tests or nucleic acid amplification testing for Mycobacterium tuberculosis. Patients without microbiological confirmation were diagnosed based on clinical manifestations. Patients were categorised into two groups based on whether they received standard anti-TB therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-TB therapy alone (non-intrathecal therapy group). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Treatment Interventions Patients who underwent at least one lumbar puncture and spinal canal administration of glucocorticoids during hospitalisation were classified as receiving intrathecal (IT) therapy. Dexamethasone was the glucocorticoid administered intrathecally at a dose of 5 mg per administration. All patients also received oral or intravenous anti-TB regimens, which included at least isoniazid and rifampicin for drug-sensitive TBM cases. Patients diagnosed with or suspected of having drug-resistant TBM who required second-line anti-TB drugs were excluded from the study.
Key inclusion criteria (1 listed)
- 1. A positive pathogenic diagnosis of tuberculous meningitis, or clinical diagnosis of tuberculous meningitis, refer to the 《2019 Chinese guidelines for the diagnosis and treatment of central nervous system tuberculosis》; 2. Complete patient information can be found, included patients' demographic characteristics, medical histories, presenting signs and symptoms, clinical course, laboratory test results, diagnostic studies, treatments, complications; 3. Patients can be collected from the time of diagnosis and medication to 12 months.
Key exclusion criteria (1 listed)
- 1. HIV positive patients (as HIV positive patients in China require diagnosis and treatment in specific healthcare systems); 2. Patients who are unable to collect complete demographic information, diagnostic and treatment information, or treatment outcomes.
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 |
|---|---|---|
| Intrathecal TherapyPatients who underwent at least one lumbar puncture and spinal canal administration of glucocorticoids during hospitalisation were classified as receiving intrathecal (IT) therapy. Dexamethasone was the glucocorticoid administered intrathecally at a dose of 5 mg per administration. All patients also received oral or intravenous anti-TB regimens, which included at least isoniazid and rifampicin for drug-sensitive TBM cases. Patients diagnosed with or suspected of having drug-resistant TBM who required second-line anti-TB drugs were excluded from the study. | Procedure or surgery | central nervous system tuberculosis |
Primary outcome
all-cause mortality within 12 months of treatment initiation
Time frame: From clear diagnosis to the following 12 months.
The primary endpoint was all-cause mortality within 12 months of treatment initiation.
1 secondary outcome
Disability rate
Time frame: 12 months
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 6 Feb 2025.
- Individual participant dataSharing planned: No. We have a requirement that hospital information and patient information cannot be shared casually.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculous Meningitis, run by Beijing Chest Hospital.
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 1 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
all-cause mortality within 12 months of treatment initiation (time frame: From clear diagnosis to the following 12 months.). 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 6 Feb 2025.