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. 2018 Apr 19;19:237. doi: 10.1186/s13063-018-2608-5

Table 1.

Patient inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
1. Age 0–16 years
2. Weight ≥ 3 kg
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; intrathoracic uncomplicated (hilar) lymph node TB
b. minimal or no parenchymal abnormality on CXR
c. 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 > 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.
1. Smear-positive respiratory sample
2. Premature (< 37 weeks) and aged under 3 months
3. Miliary tuberculosis (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 ill
9. Pregnancy