ISRCTN40829906进行中（未招募）3 期
A randomised trial of 6 months enhanced anti-tuberculosis and 2 months anti-inflammatory treatment for HIV-infected and HIV-uninfected African and Asian children with tuberculous meningitis
niversity College London0 个研究点目标入组 369 人开始时间: 2018年11月13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
- 369
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 22/08/2024:
- •1. Aged between 29 days and <18 years old
- •2. Weight =3 kg
- •3. Symptoms compatible with tuberculosis meningitis (TBM), including fever, vomiting, anorexia, listlessness and headache
- •4. Cerebrospinal fluid (CSF) result with abnormalities compatible with TBM (elevated cell count and/or protein with or without M. tuberculosis detected by microscopy or GeneXpert). Physician believes the child needs immediate initiation of anti-TB drugs.
- •5. Known (or pending confirmation of) HIV status
- •6. Parent/carer give informed, written consent
- •7. CSF sample processed for chemistry, microscopy, Ziehl–Nielsen or auramine stain and, mycobacterial culture (in process) and, where available, Xpert (Gene Xpert/Rif or Xpert Ultra) prior to commencing treatment. Where patients have already been started on ATT, pre-screening CSF results should be available.
- •8. Carer/parent can comply with the protocol requirements in the opinion of the site investigator
- •9. Home address accessible for visiting and intending to remain within the recruitment area for follow up period of at least 18 months
- •Previous inclusion criteria:
- •1. Aged between 29 days and 15 years
- •2. Weight =3 kg
- •3. Symptoms compatible with tuberculosis meningitis (TBM), including fever, vomiting, anorexia, listlessness and headache
- •4. Cerebrospinal fluid (CSF) result with abnormalities compatible with TBM (elevated cell count and/or protein with or without M. tuberculosis detected by microscopy or GeneXpert). Physician believes the child needs immediate initiation of anti-TB drugs.
- •5. Known (or pending confirmation of) HIV status
- •6. Parent/carer give informed, written consent
- •7. CSF sample processed for chemistry, microscopy, Ziehl–Nielsen or auramine stain and, mycobacterial culture (in process) and, where available, Xpert (Gene Xpert/Rif or Xpert Ultra) prior to commencing treatment. Where patients have already been started on ATT, pre-screening CSF results should be available.
- •8. Carer/parent can comply with the protocol requirements in the opinion of the site investigator
- •9. Home address accessible for visiting and intending to remain within the recruitment area for follow up period of at least 18 months
排除标准
- •1. Recent contact (last 12 months) with known or suspected rifampicin-resistant TB
- •2. Proven drug resistance to rifampicin in the child
- •3. On ATT for >7 days
- •4. Severely moribund - high risk of death within 24 hours
- •5. History or presence of known allergy or other contraindication to any of the following:
- •5.1. First-line anti-tuberculosis drugs
- •5.2. Corticosteroids
- •5.3. Aspirin
- •6. Pregnancy
- •7. History of gastrointestinal (GI) bleeding or bleeding diathesis
- •8. Active clinical infection with influenza or varicella
- •9. Grade 4 liver toxicity or other contraindications for taking part in the trial
研究者
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