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Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis infection, causing mortality and disability in more than half of the patients. Current standard treatment for TBM is based on those developed to treat pulmonary tuberculosis, which does not take into account the differential ability of anti-tuberculosis drugs to penetrate the brain. With both good central nervous system penetrance and anti-tuberculosis efficacy that have been demonstrated in drug-resistant tuberculosis, linezolid may be a promising antimicrobial in TBM treatment. The purpose of this study is to evaluate the effectiveness of linezolid in the treatment of TBM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Background group | The treatment regimen does not include linezolid throughout the treatment course. | ||
| Background-linezolid group | Linezolid was added in the middle of the treatment course but not in the initial treatment regimen. |
| |
| Linezolid initial group | Linezolid was in initial treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug | To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Medical Research Council grade deterioration | From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Glasgow Coma Scale recovered to 15 | From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years. | |
| Time of body temperature returns to normal | From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian Zhou | Contact | (86)18801734036 | zhouxian-13@163.com | |
| Feng Sun | Contact | aaronsf1125@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious department of Huashan Hospital, Fudan University | Recruiting | Shanghai | 200040 | China |
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| ID | Term |
|---|---|
| D014390 | Tuberculosis, Meningeal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Number of participants with new omplications | Hydrocephalus, cerebral infarction, epilepsy, brain abscess, tuberculoma | From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years. |
| D007239 | Infections |
| D020306 | Tuberculosis, Central Nervous System |
| D000092225 | Tuberculosis, Extrapulmonary |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |