ISRCTN61649292已完成4 期
A randomised, double-blind, placebo-controlled trial to investigate the effect of intensified treatment with high dose rifampicin and levofloxacin for adult patients with tuberculous meningitis
niversity of Oxford (UK)0 个研究点目标入组 817 人开始时间: 2009年10月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 817
研究概览
简要总结
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288325 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288326 2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26760084 2020 results in https://pubmed.ncbi.nlm.nih.gov/31956998/ (added 28/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Greater or equal to 15 years of age (either sex) with a clinical diagnosis of tuberculous meningitis
排除标准
- •1. Positive cerebrospinal fluid (CSF) Gram or India Ink stain
- •2. Known or suspected pregnancy
- •3. Known hypersensitivity/intolerance to fluoroquinolones or rifampicin
- •4. Estimated glomerular filtration rate (GFR) less than 40 ml/min
- •5. Laboratory contraindications to antituberculous therapy:
- •5.1. Bilirubin greater than 2.5 x upper limit of normal (ULN)
- •5.2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 x ULN
- •6. Lack of consent
研究者
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