Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

NCT ID: NCT06811792

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 837 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Tuberculous Meningitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Intrathecal Therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nie WenJuan

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GCP-TB-2024-9-30

Identifier Type: -

Identifier Source: org_study_id