Table 1.

Eligibility criteria for randomisation

Inclusion criteria

Exclusion criteria

Aged ≥15 years TST positive (a size of 10 mm or greater at first reading); OR Any TST size if known to be HIV positive or severely malnourished; OR New TST conversion on the second reading, defined as: If the first test was <5 mm a size of 10 mm or greater at second reading; OR If the first test was 5–9 mm: An increase of 6 mm or greater at the second reading

A diagnosis of current active TB disease made during initial assessment¶ Known to be pregnant* Unable to take oral medication Body weight <3 kg Unwilling or unable to participate in follow-up for 30 months Currently breast feeding* Known allergy to fluoroquinolone antibiotics, or history of severe tendinopathy related to fluoroquinolones Currently taking another medication reported to increase the cardiac QTc interval (eg, amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine) Documented previous treatment for MDR-TB Documented treatment with antibiotics that are active against MDR-TB in the previous month (including fluoroquinolones) Prior severe blistering reaction to tuberculin End-stage liver failure (class Child-Pugh C) Dialysis-dependent chronic kidney disease A baseline liver function test (AST, ALT or ALP) more than three times the upper limit of normal Kidney tests show end-stage kidney disease (defined as an EGFR <20 mL/min) The platelet count is <50×109 cells/L For adults aged 15 and above only: Baseline ECG shows the QT segment (corrected for the R-R interval) is >450 ms

*Women who are pregnant may be randomised after they have delivered and finished breast feeding. Women of childbearing age will be offered a urinary pregnancy test, though this will not be required as a condition of randomisation.

†¶Initial assessment for active TB disease: At the time of enrolment, contacts aged ≥15 years will be assessed for active disease, includingclinical assessment (including history and physical examination), plain chest radiograph and sputum microbiology (testing with Xpert, regardless of symptoms). This will be performed on: (a) all contacts aged 15 and above who are eligible to be randomized, and who are able to produce a sputum sample, and (b) all subjects aged 5 and above suspected to have TB

ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate aminotransferase; EGFR, estimated glomerular filtration rate; MDR-TB, multidrug-resistant tuberculosis; QT_c, corrected QT segment; TB, tuberculosis; TST, tuberculin skin test.