Tuberculous meningitis (TBM)
Conditions
Interventions
Control group:No Dramani anti-TB regimen
Study group:Anti-tuberculosis treatment regimen with Delamani
Sponsors
Changchun Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The inclusion criteria for drug-resistant tuberculous meningitis were met. 2.Male or female between the ages of 18 and 65. 3.Participants who are fertile or likely to have children should use effective contraception during the study; 4.Subjects (or their legal representatives/guardians) understand the study procedures and content, sign informed consent, and are willing to accept Dramani treatment patients.
Exclusion criteria
Exclusion criteria: 1.Those who do not meet the inclusion criteria or have severe allergies (e.g., atopic dermatitis, bronchial asthma); 2.Pregnant or lactating women; 3.Patients 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; 4.Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic diseases that may affect the study and may interrupt the course of treatment; 5.Patients who cannot receive normative anti-tuberculosis therapy due to pre-existing underlying diseases or other reasons; 6.Total bilirubin > 3 times, or 5 times the upper limit of normal glutamic pyruvic transaminase [ALT] or glutamic oxalacetic transaminase [AST] [ULN]; 7.Patients with persistent epilepsy; 8.HIV infection, long-term use of immunosuppressive therapy; 9.Within 1 month before enrollment, have received other drug or medical device intervention clinical study; Or other factors related to this study that need to be excluded; 10.0CrCl 30 mL/ min or oliguria that does not respond to fluid rehydration < 20 mL/ hour, or any form of dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Cerebrospinal fluid drug concentration;Cerebrospinal fluid routine, biochemistry;Imaging indicators;Physical signs and physical examination;Changes in Microbiology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine examination;Liver function, kidney function;Q-T interval; | — |
Countries
China
Contacts
Public ContactGuixiang Qin
Changchun Infectious Disease Hospital
Outcome results
None listed