ISRCTN63579542已完成3 期
A randomised trial of therapy shortening for minimal tuberculosis with new WHO-recommended doses/ fixed-dose-combination drugs in African and Indian HIV-positive and HIV-negative children
niversity College London (UK)0 个研究点目标入组 1,204 人开始时间: 2014年10月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,204
研究概览
简要总结
2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29673395/ protocol (added 16/06/2020) 2019 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6903808/ acceptability results (added 16/06/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34420049/ Pharmacokinetics results (added 10/03/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32493780/ Substudy results (added 10/03/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35263517/ (added 10/03/2022)
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 27/05/2021:
- •1. Aged 0-16 years
- •2. Weight =3kg. This has been expanded to include children weighing between 3 and 4kg; a detailed PK study of individual drugs in infants is ongoing and data using the new FDC from this study will ensure that use of this new formulation is also studied in these smallest infants.
- •3. Clinician has decided to treat with standard first-line regimen (intensive phase of 4 drugs or 3 drugs as per local practice)
- •4. symptomatic but non-severe TB including:
- •4.1. extrathoracic lymph node TB; intra-thoracic uncomplicated (hilar) lymph node TB
- •4.2. minimal or no parenchymal abnormality on CXR
- •4.3. smear negative on gastric aspirate/other respiratory sample
- •Note: GeneXpert may be positive or negative and a negative GeneXpert can be used as a substitute for a negative smear; culture of respiratory sample may be positive or negative; lymph node aspirate may be smear/culture/GeneXpert positive or negative)
- •5. Not treated for previous TB unless successfully treated over 2 years since last completed treatment
- •6. Known (or pending confirmation of) HIV status; HIV-infected or HIV-uninfected
- •7. Willing and likely to adhere to 72 weeks follow up
- •8. Informed written consent from the parent/legal caregiver(s) and assent in children, as per local Ethics Committee guidance
- •9. Home address accessible for visiting and intending to remain within the recruitment area for follow up
- •Previous inclusion criteria:
- •1. Aged 0-16 years
- •2. Weight over 4 kg
- •3. Clinician has decided to treat with standard first-line regimen
- •4. Asymptomatic or symptomatic but non-severe TB including:
- •4.1. extrathoracic lymph node TB; intra-thoracic uncomplicated lymph node TB
- •4.2. minimal or no parenchymal abnormality on CXR
- •4.3. smear gastric aspirate/other respiratory sample (minimum 2 samples) negative
- •5. Not previously treated for TB or successfully treated for TB over 2 years since last completed treatment
- •6. Known HIV status; HIV-infected or HIV-uninfected
- •7. Willing and likely to adhere to 72 weeks follow up
- •8. Informed written consent from the parent/legal caregiver(s)
- •9. Home address accessible for visiting and intending to remain within the recruitment area for follow up
排除标准
- •Current exclusion criteria as of 27/05/2021:
- •1. Smear-positive respiratory sample TB (note: smear-positive peripheral lymph node sample is allowed)
- •2. Premature (<37 weeks) and aged under 3 months
- •3. Miliary TB, spinal TB, TB meningitis, osteoarticular TB, abdominal TB, congenital TB
- •4. Pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. liver or kidney disease, peripheral neuropathy, cavitation
- •5. Any known contraindication to taking anti-TB drugs
- •6. Known contact with drug resistant adult source case (including mono-resistant TB)
- •7. Known drug resistance in the child
- •8. Severely sick
- •9. Pregnancy
- •Previous exclusion criteria:
- •1. Smear-positive respiratory sample TB (note: smear-positive peripheral lymph node sample is allowed)
- •2. Premature (<37 weeks) and aged under 3 months
- •3. Miliary TB, spinal TB, TB meningitis, osteoarticular TB, abdominal TB, congenital TB
- •4. Pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. liver or kidney disease, peripheral neuropathy, cavitation
- •5. Any known contraindication to taking anti-TB drugs
- •6. Known contact with MDR, pre-XDR or XDR adult source case
- •7. Proven anti-TB drug resistance in the child
- •8. Severely sick
- •9. Pregnancy
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