A randomised trial of therapy shortening for minimal tuberculosis with new WHO-recommended doses/fixed-dose-combination drugs in African and Indian HIV+ and HIV- children

niversity College London0 个研究点目标入组 1,200 人开始时间: 2015年5月14日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Age 0-16 years
•2. Weight ¿ 3kg.
•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:
•a)extrathoracic lymph node TB; intra-thoracic uncomplicated (hilar) lymph node TB
•b) minimal or no parenchymal abnormality on CXR
•c) smear gastric aspirate/other respiratory sample (minimal 2 samples) negative
•Note: GeneXpert may be positive or negative; culture of respiratory sample may be positive or negative; lymph node aspirate may be smear/culture/GeneXpert positive or negative)
•5. Not previously treated for TB or successfully treated for TB >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) 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

•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-extisting 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 contract with MDR, pre-XDR or XDR adult source case
•7. Proven drug resistance in the child (R resistance with or without H resistance), H mono-resistance allowed
•8. Severely sick
•9. Pregnancy

发起方

niversity College London