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Clinical study on efficacy and safety of regimen containing Linezolid in the treatment of tuberculous meningitis

Clinical study on efficacy and safety of regimen containing Linezolid in the treatment of tuberculous meningitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076246
Enrollment
Unknown
Registered
2023-09-28
Start date
2022-05-31
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Tuberculous meningitis

Interventions

Intervention:Add linezolid to standard antituberculousis regimen
Control group:Standard antituberculosis regimen

Sponsors

Shenzhen Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as tuberculous meningitis who meet the diagnostic criteria of "2019 Chinese Guidelines for the Diagnosis and Treatment of Central Nervous System Tuberculosis". 2. above 0 years old; 3. Anti-tuberculosis treatment period should not exceed 1 week; 4. Patients under the age of 18 should be enrolled after signing the informed consent form (the guardian should give informed consent and sign for confirmation).

Exclusion criteria

Exclusion criteria: 1. AIDS. 2. Severe liver and kidney dysfunction (TBIL>2ULN, ALT or AST>5ULN, decompensated cirrhosis ccr<30ml/min). 3. Abnormal hemogram (WBC<2.0*10^9/L, N<0.5*10^9/L, HGB<60g/L, PLT<20*10^9/L) and bone marrow suppression confirmed by bone marrow puncture. 4. Seriously allergic or other contraindications to the anti-tuberculosis drugs or glucocorticoid. 5. Rifampicin-resistant or multidrug-resistant tuberculosis 6. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Mortality;

Secondary

MeasureTime frame
Incidence of SAE;Changes in GSC scores and BMRC grading at 2 and 4 weeks;

Countries

China

Contacts

Public ContactMutong Fang

Shenzhen Third People's Hospital

1049179464@qq.com+86 136 3266 4920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026