Clinical trial NCT06811792: Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes
Official title: Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculous Meningitis
Keywords: Intrathecal Therapy
Tuberculous Meningitis
Outcome
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 837
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: all-cause mortality within 12 months of treatment initiation
timeFrame: From clear diagnosis to the following 12 months.
Secondary outcomes:
measure: Disability rate
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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