Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

• Conditions: Tuberculous Meningitis
• Interventions: Drug: Linezolid

• Registration Number: NCT03898635
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• all patients diagnosed as TBM from the electronic medical record system.

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Exclusion Criteria

• Does not meet the established diagnostic criteria;
• Combine other pathogen central infections;
• Follow-up confirmed that the final diagnosis considers other diseases (such as tumors, autoimmune encephalitis, etc.);
• Our hospital has less than one week of anti-tuberculosis treatment;
• Lack of information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Background-linezolid group	Linezolid	Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.
Linezolid initial group	Linezolid	Linezolid was in initial treatment regimen.

Primary Outcome Measures

Name	Time	Method
Survival	5 years

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Infectious department of Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China