NCT06811792

Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 837 (actual)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculous Meningitis

Interventions

Type	Name	Description
PROCEDURE	Intrathecal Therapy	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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2025-02-06
• Last updated: 2025-02-06