Table 1.
Clinical and Demographic Characteristics of the Study Population
| Patients by Treatment Arma |
||||
|---|---|---|---|---|
| Characteristic | Isoniazid (n = 506) | Rifapentine Plus Isoniazid (n = 552) | Total (N = 1058) | P Valueb |
| Indication for treatment of LTBI | ||||
| Close contact | 470 (92.9) | 519 (94.0) | 989 (93.5) | .46 |
| Recent TST result converter | 36 (7.1) | 33 (5.9) | 69 (6.5) | .46 |
| Age, median (IQR) | 12 (4–15) | 10 (4–15) | 11 (4–15) | .02 |
| Male sexc | 241 (47.6) | 297 (53.8) | 538 (50.9) | .005 |
| 2–4 y | 66 (13.0) | 85 (15.4) | 151 (14.3) | |
| 5–11 y | 45 (8.9) | 68 (12.3) | 113 (10.7) | |
| 12–17y | 130 (25.7) | 144 (26.1) | 274 (25.9) | |
| Race/ethnicity | ||||
| North America | ||||
| White Hispanicc | 301/431 (69.8) | 337/453 (74.4) | 638/884 (72.2) | .13 |
| 2–4 y | 92/431 (21.3) | 113/453 (24.9) | 205/884 (23.2) | |
| 5–11 y | 82/431 (19.0) | 93/453 (20.5) | 175/884 (19.8) | |
| 12–17 y | 127/431 (29.5) | 131/453 (28.9) | 258/884 (29.2) | |
| White non-Hispanicc | 18/431 (4.2) | 22/453 (4.9) | 40/884 (4.5) | .75 |
| 2–4 y | 2/431 (0.5) | 3/453 (0.7) | 5/884 (0.6) | |
| 5–11 y | 2/431 (0.5) | 6/453 (0.1) | 8/884 (0.9) | |
| 12–17 y | 14/431 (3.2) | 13/453 (2.9) | 27/884 (3.1) | |
| Blackc | 56/431 (13.0) | 51/453 (11.3) | 107/884 (12.1) | .47 |
| 2–4 y | 11/431 (2.6) | 17/453 (3.8) | 28/884 (3.2) | |
| 5–11 y | 8/431 (1.9) | 8/453 (1.8) | 16/884 (1.8) | |
| 12–17 y | 37/431 (8.6) | 26/453 (5.7) | 63/884 (7.1) | |
| Otherc | 56/431 (13.0) | 43/453 (9.5) | 99/884 (11.2) | .11 |
| 2–4 y | 13/431 (3.0) | 11/453 (2.4) | 24/884 (2.7) | |
| 5–11 y | 7/431 (1.6) | 15/453 (3.3) | 22/884 (2.5) | |
| 12–17 y | 36/431 (8.4) | 17/453 (3.8) | 53/884 (6.0) | |
| Brazilc,d | 73/504 (14.5) | 98/551 (17.8) | 171/1055 (16.2) | .16 |
| 2–4 y | 10/504 (2.0) | 24/551 (4.4) | 34/1055 (3.2) | |
| 5–11 y | 9/504 (1.8) | 11/551 (2.0) | 20/1055 (1.9) | |
| 12–17y | 54/504 (10.7) | 63/551 (11.4) | 117/1055 (11.1) | |
| Enrollment site | ||||
| US/Canada | 431 (85.2) | 453 (82.1) | 884 (83.6) | .18 |
| Brazil/Spain/Hong Kong | 75 (14.8) | 99 (17.9) | 174 (16.4) | .18 |
| HIV seropositivee | 1/111 (0.9) | 4/105 (3.8) | 5/216 (2.3) | .20 |
| Persons enrolled in a cluster | 155 (30.6) | 197 (35.7) | 352 (33.3) | .09 |
| TST reaction size, median (IQR), mmc,f | 15 (11–20) | 15 (12–20) | 15 (12–20) | |
| 2–4 y | 14 (11–18) | 15 (13–20) | 15 (12–20) | .46 |
| 5–11 y | 15 (12–20) | 15 (12–20) | 15 (12–20) | |
| 12–17y | 15 (11–20) | 15 (11–19) | 15 (11–20) | |
| BMI, median, (IQR)c | 19 (17–23) | 19 (16–23) | 19 (17–23) | |
| 2–4 y | 16 (15–18) | 17 (15–18) | 16 (15–18) | .29 |
| 5–11 y | 17 (16–20) | 18 (16–21) | 18 (16–21) | |
| 12–17y | 22 (19–26) | 22 (20–26) | 22 (20–26) | |
| Homeless | 5 (0.9) | 3 (0.5) | 8 (0.8) | .49 |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); HIV, human immunodeficiency virus; IQR, interquartile range; LTBI, latent tuberculosis infection; TST, tuberculin skin test.
Includes all children aged 2 to 17 years. Data are presented as number/total (percentage) unless otherwise specified.
P values are for Fisher exact test comparing proportions and the median scores for comparing continuous distributions. Although randomization was unrestricted, there was evidence in the parent study that household-based clustering resulted in some imbalance between arms.
P value refers to the overall characteristic by regimen, not age group.
Race not reported in US categories. Three children were outside North America or Brazil: 2 in the 5 to 11 age group and 1 in the 12 to 17 age group.
Of children with known HIV status.
Of children with TST result size greater than 0 mm (combined total, 929; 449 in the isoniazid-only group and 480 in the combination-therapy group). A total of 129 close contacts had enrollment TST result size of zero; of these, 128 were younger than 5 years, and 1 was aged 12 years and HIV seropositive.