ISRCTN42218549已完成2 期
High dose oral and intravenous rifampicin for improved survival of adult Tuberculous meningitis: a phase II open-label randomised controlled trial
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 61 人开始时间: 2018年4月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
研究概览
简要总结
2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30175245/ protocol (added 06/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33693537/ (added 08/11/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Provision of written informed consent by participant or surrogate
- •3. Clinical diagnosis of TBM: meningitis symptoms, clinical signs of meningism and antituberculous chemotherapy planned by the attending physician
- •4. Bedside CSF glucose to plasma ratio <50%, or absolute CSF glucose <40mg/dl or 2.2 mmol/L
- •5. Positive CSF AFB smear or Xpert MTB/ Rif or Ultra
排除标准
- •1. Presence of jaundice or known liver cirrhosis (Due to emergent need to begin TBM therapy to reduce mortality, enrolment will not be delayed and participants will be replaced a posteriori if baseline ALT>3x ULN)
- •2. Greater than 3 doses of TB treatment received within the previous 3 days (induction of cytochrome P450 enzymes occurs after 3-5 days of rifampicin therapy which would affect PK data)
- •3. Discontinued TB treatment in the prior 14 days (induction of cytochrome P450 enzymes persists for up to 2-weeks after cessation of R and would make interpretation of the PK data challenging)
- •4. Known allergy to Rifamycins, H, Z, E or study drug excipients
- •5. Known current/previous rifampicin drug-resistant M. tuberculosis infection
- •6. Current cryptococcal meningitis: India ink stain positive or culture positive or cryptococcal antigen positive in the absence of prior effective treatment and prophylaxis.
- •7. Use of any drug that has a clinically relevant interaction with rifampicin or other first-line TB drugs, including ritonavir, atazanavir or darunavir (see appendix 2 for further detail)
- •8. Cannot or unlikely to attend regular clinic visits
- •9. Pregnancy / Breastfeeding. Women of childbearing potential must agree to use barrier contraception or abstinence for 8 weeks. Hormonal contraception is unacceptable as rifampicin induces metabolism.
- •10. Lack of consent from participant or family member
- •11. Known porphyria
- •12. Known chronic renal failure with eGFR <10 ml/min
研究者
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