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. Author manuscript; available in PMC: 2022 Mar 14.
Published in final edited form as: N Engl J Med. 2022 Mar 10;386(10):911–922. doi: 10.1056/NEJMoa2104535

Table 1. Baseline characteristics, baseline clinical presentation and AFB smear and culture of children in SHINE.

16 weeks
(N=602)
24 weeks
(N=602)
Total
(N=1204)
Sex N (%) Female 297 (49) 286 (48) 583 (48)
Age (Years) Median (IQR), (Min,Max) 3.4 (1.5, 6.9), (2m, 15y) 3.5 (1.5, 7.1), (2m, 15y) 3.5 (1.5, 7.0), (2m, 15y)
Site country
South Africa 156 (26) 159 (26) 315 (26)
Uganda 188 (31) 188 (31) 376 (31)
Zambia 183 (30) 181 (30) 364 (30)
India 75 (12) 74 (12) 149 (12)
HIV status, N (%) Positive 65 (11) 62 (10) 127 (11)
WHO weight band (kg), N (%) 3-3.9 0 3 (1) 3 (<1)
4-7.9 86 (14) 92 (15) 178 (15)
8-11.9 162 (27) 152 (25) 314 (26)
12-15.9 126 (21) 116 (19) 242 (20)
16-24.9 142 (24) 153 (25) 295 (25)
≥25 86 (14) 86 (14) 172 (14)
Clinical Presentation N (%) Respiratory 398 (66) 406 (67) 804 (67)
Mixed respiratory and peripheral TB 182 (30) 171 (28) 353 (29)
Peripheral lymph node TB 19 (3) 21 (3) 40 (3)
Other ¥ 3 (1) 4 (1) 7 (1)
MTB culture and Xpert MTB/RIF results θ N (%) Total (culture positive for MTB (MGIT or LJ) OR Xpert MTB/RIF positive) 85 (14) 80 (13) 165 (14)
TB culture positive only 40 (7) 40 (7) 80 (7)
Xpert MTB/RIF positive only 14 (2) 5 (1) 19 (2)
TB culture positive AND Xpert MTB/RIF positive 31 (5) 35 (6) 66 (5)

Data presented as number of participants (%), unless otherwise stated. IQR=interquartile range, LJ=Lowenstein Jensen solid culture medium, MGIT =mycobacteria growth indicator tube liquid culture system, y=years, m=months, RIF=rifampicin, Xpert=GeneXpert.

θ

_Microbiological confirmation was from respiratory samples (gastric aspirate/washing, induced or expectorated sputum) and fine needle aspiration of enlarged lymph nodes and was defined as positive for M. tuberculosis by culture or Xpert MTB/RIF assay.

¥

Participants did not have a cough for more than 2 weeks or peripheral lymph node(s) suggestive of TB.