ISRCTN15668391进行中（未招募）3 期
High-dose oral rifampicin to improve survival from adult tuberculous meningitis: a double-blinded randomised placebo-controlled Phase III trial
Makerere College of Health Sciences0 个研究点目标入组 500 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33083560/ protocol (added 23/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. First episode TBM suspected by attending physician (>3 days of meningitis symptoms and CSF abnormalities) and anti-TB treatment planned
- •2. Age =18 years
- •3. Provision of written informed consent by participant or surrogate
排除标准
- •1. Presence of jaundice, known liver cirrhosis, or known elevated ALT >5x ULN
- •2. More than 5 doses of any TB treatment received within the previous 7 days
- •3. Known allergy to: isoniazid, rifampicin, ethambutol, or pyrazinamide
- •4. Known current/previous rifampicin-resistant M.tb infection
- •5. Additional active and confirmed CNS infection
- •6. Corticosteroids contraindicated
- •7. Cannot or unlikely to attend regular clinic visits
- •8. Pregnancy or breastfeeding
- •9. Known renal failure with eGFR <30 ml/min by Modification of Diet in Renal Disease (MDRD) Study equation
- •10. HIV Protease Inhibitor ongoing use
研究者
相似试验
已完成
2 期
Improving diagnosis and treatment of HIV-associated Tuberculous meningitisTuberculosis of nervous systemInfections and InfestationsTuberculous meningitisISRCTN42218549ondon School of Hygiene and Tropical Medicine61
已完成
不适用
Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemiaS. aureus (meticillin-susceptible or resistant) infection, acute infectionInfections and InfestationsStaphylococcus aureus as the cause of diseases classified to other chaptersISRCTN37666216Medical Research Council (MRC) (UK)770
已完成
2 期
Trial of High-Dose Rifampin in Patients With TBTuberculosisNCT01408914Harvard University Faculty of Medicine180
Unknown
2 期
Rifampicin at High Dose for Difficult-to-Treat TuberculosisTuberculosisNCT04768231Hospital Universitari Vall d'Hebron Research Institute130
已完成
1 期
Phenotyping of High Dose RifampicinTuberculosisNCT04525235Radboud University Medical Center25