PACTR201505001141379Not yet recruiting未知
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 sites1,200 target enrollmentStarted: May 14, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 Year(s) to 16 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
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-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
Investigators
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