Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

Beijing Chest Hospital

Status: Completed

Conditions: Tuberculous Meningitis

Treatments: Procedure: Intrathecal Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06811792

GCP-TB-2024-9-30

Details and patient eligibility

About

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.

Enrollment: 837 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

837 participants in 1 patient group

central nervous system tuberculosis

Description:

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).

Treatment:

Procedure: Intrathecal Therapy