跳至主要内容
临床试验/NCT03898635
NCT03898635Unknown不适用

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

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Background-linezolid group

Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.

干预措施: Linezolid (Drug)

Linezolid initial group

Linezolid was in initial treatment regimen.

干预措施: Linezolid (Drug)

结局指标

主要结局

Survival

时间窗: 5 years

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-hong Zhang

Director of Division of Infectious Diseases

Huashan Hospital

研究点 (1)

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