Status:
UNKNOWN
Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Tuberculous Meningitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The genetically polymorphic N-acetyltransferase type 2 (NAT2) is responsible for isoniazid metabolism, and rapid acetylators were associated with low concentrations of isoniazid based on previous stud...
Detailed Description
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis, causing death or severe neurologic deficits in more than half of those affected in spite of antituberculosis chemotherapy. Among t...
Eligibility Criteria
Inclusion
- 18 to 65 years of age;
- Clinical diagnosis of TBM;
- Able and willing to provide informed consent to participate in the study.
Exclusion
- Using any other second line antituberculosis drug;
- Received anti-tuberculosis therapy in the past 3 years；
- Positive CSF Gram or India ink stain;
- Received more than 14 days of anti-tuberculosis drugs for the current infection;
- Known or suspected hypersensitivity to or unacceptable side effects from any oral first line antituberculosis drug;
- Plasma creatinine concentration was more than the upper limit of the normal range, or the plasma bilirubin concentration was more than 2 times the upper limit of the normal range, or the plasma alanine aminotransferase level was more than three times the upper limit of the normal range;
- Known or suspected pregnancy;
- Known or suspected isoniazid and/or rifampin resistant;
- Lack of consent；
- Any participant for whom investigators judge this study is not appropriate.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT03787940
Start Date
March 4 2019
End Date
December 31 2021
Last Update
February 1 2021
Active Locations (4)
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1
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, China
2
Jiamusi Infectious Disease Hospital
Jiamusi, China
3
Jiangxi Provincial Chest Hospital
Nanchang, China
4
Zunyi Medical College affiliated Hospital
Zunyi, China