Table 1 Patient inclusion and 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