tuberculous meningitis
Conditions
Interventions
Contezolide group:Contezolide was given on the basis of the basic treatment regimen
Linezolid group:Linezolid was given on the basis of the basic treatment regimen
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. =18 years old, regardless of gender or weight; 2. Patients diagnosed with tuberculous meningitis or highly suspected of tuberculous meningitis; 3. Female subjects must meet the following conditions: (1) have been menopausal for at least 1 year, or (2) have undergone sterilization, or (3) if they are fertile, they must also meet the following conditions: At the time of enrollment, they must ask the patient to confirm that they are not pregnant in the form of medical history, take reliable contraceptive measures during the trial, and are not breastfeeding; Male and female participants were required to use effective contraception during the study period and for 1 month after the study. 4. Subjects (or their legal representatives/guardians) understand the procedure and content of the study, voluntarily sign the informed consent, and are willing to participate in the study;
Exclusion criteria
Exclusion criteria: 1. Stage III was determined by the modified MRC (British Medical Research Council) staging criteria for tuberculous meningitis Of patients; 2. Patients who are allergic to treatment regimens such as oxazolidinones used in the treatment regimens; 3. Patients with known or highly suspected rifampicin resistance; 4. Patients with bacterial, fungal, viral or parasitic meningitis; 5. Patients who have previously received anti-nodule regimen containing contezolid or linezolid for =1 month; Received within 2 weeks before enrollment Contezolid, linezolid treatment; 6. Patients who had received fluoroquinolone antibiotics and amikacin within 2 weeks before enrollment; 7. Patients with unstable blood sugar control; 8. Patients who are unable to administer oral drugs independently or have gastrointestinal diseases that will seriously affect the absorption of oral drugs; 9. Organ transplant recipients; 10. Malignant tumor; 11. Those who are expected to survive less than 12 months; 12. Patients with persistent epilepsy; 13. Long-term immunosuppressive therapy; 14. Patients with severe liver function impairment (Hay's rule criteria: patients with serum ALT (or AST) elevated =3×ULN, TBil elevated High >2×ULN); 15. Severe renal impairment: eGFR less than 30ml/min; 16. Persons positive for human immunodeficiency virus (HIV); 17. People with coagulation disorders; 18. Patients who cannot cooperate with lumbar puncture; 19. Those who are not suitable to participate in the clinical study or who have influence on the evaluation of the study are considered by the researcher for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;Early clinical response rate;Changes in CSF (cerebrospinal fluid glucose/blood glucose ratio, cerebrospinal fluid protein content, cerebrospinal fluid white blood cell count);Microbial conversion rate; | — |
Countries
China
Contacts
Public ContactWenhong Zhang
Huashan Hospital Fudan University
Outcome results
None listed