Central nervous system tuberculosis
Conditions
Interventions
Experimental Group:Drug intervention: Cantizolamide anti-tuberculosis therapy
Control Group:Drug intervention: Linezolid anti-tuberculosis therapy
Sponsors
Changchun Infectious Diseases Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Male or female =18 years of age; (2) include one or more of the following symptoms and signs of meningitis: headache, irritability, vomiting, fever, stiff neck, convulsions, focal neurological deficits, altered consciousness, or lethargy; (3) Positive etiological evidence of Mycobacterium tuberculosis, meeting the following criteria A or B:A.Meet one or more of the following criteria: ?Acid-fast bacilli found in cerebrospinal fluid;? MTB culture in cerebrospinal fluid was positive;?Cerebrospinal fluid tuberculosis nucleic acid, gene test positive;B. The brain or spinal cord is found to be acid-fast bacilli or tuberculosis pathological changes, and there are clinical signs and corresponding cerebrospinal fluid changes; (4) For fertile or potential subjects, effective contraceptive measures should be taken during the study; (5) Subjects (or their legal representatives/guardians) understand the study procedures and content, sign the informed consent, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: (1) People who are allergic or severely allergic to oxazolidinones (such as: atopic dermatitis, bronchial asthma);(2) Those who cannot be administered orally or are not suitable for administration through nasal feeding/gastrointestinal nutrition tube, or have gastrointestinal diseases that will seriously affect the absorption of oral drugs; (3) Patients with stage I according to the modified UK Medical Research Council (MRC) staging criteria for tuberculous meningitis; (4) Total bilirubin >3 times, or glutamic pyruginate transaminase [ALT] or glutamic oxalate transaminase [AST]5 times the upper limit of normal [ULN]; (5) CrCl30mL/ min or oliguria 2×ULN); (10) Within 1 month before enrollment, have received other drug or medical device intervention clinical research; (11) Those who are not suitable to participate in this clinical study or have an impact on the endpoint evaluation due to various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical signs and physical examination;Imaging examination;Cerebrospinal fluid examination;Etiological examination;Blood concentration;Cerebrospinal fluid drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiogram;Blood routine examination;urinalysis;Biochemistry; | — |
Countries
China
Contacts
Public ContactLijun Han
Changchun Infectious Diseases Hospital
Outcome results
None listed