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Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06811792
Enrollment
837
Registered
2025-02-06
Start date
2010-01-01
Completion date
2024-12-31
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculous Meningitis

Keywords

Intrathecal Therapy, Tuberculous Meningitis, Outcome

Brief 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. 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.

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.

Sponsors

Beijing Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortality within 12 months of treatment initiationFrom clear diagnosis to the following 12 months.The primary endpoint was all-cause mortality within 12 months of treatment initiation.

Secondary

MeasureTime frameDescription
Disability rate12 monthsThe disability rate of tuberculosis meningitis patients within 12 months after diagnosis and treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026