Table 1.
Baseline demographic and clinical characteristics of children with drug-susceptible TB in the Opti-Rif trial
| Cohort 1, N = 20 | Cohort 2, N = 22 | Cohort 3, N = 20 | Total, N = 62 | |
|---|---|---|---|---|
| Male, n (%) | 10 (50) | 10 (45.5) | 12 (60) | 32 (51.6) |
| Age (years), median (IQR; range) | 2.0 (IQR = 1.2–3.4; range = 0.4–11.4) | 2.0 (IQR = 1.1–3.9; range = 0.5–9.4) | 2.8 (IQR = 1.0–5.5; range = 0.4–11.7) | 2.1 (IQR = 1.1–4.4; range = 0.4–11.7) |
| Age group categories, n (%) | ||||
| 0 to <2 years | 10 (50) | 11 (50) | 8 (40) | 29 (46.8) |
| 2 to <6 years | 8 (40) | 8 (36.4) | 7 (35) | 23 (37.1) |
| 6 to <12 years | 2 (10) | 3 (13.6) | 5 (25) | 10 (16.1) |
| Weight (kg), median (IQR) | 10.6 (8.7–14.2) | 10.9 (9.3–14.1) | 12.5 (8.0–17.4) | 10.6 (8.6–15.9) |
| Weight-for-age z-score, median (IQR) | −1.42 (−2.13 to −0.73) | −0.80 (−1.96 to −0.26) | −1.60 (−2.40 to −0.83) | −1.37 (−2.10 to −0.55) |
| Height/length (cm), median (IQR) | 80.5 (70.5–95.0) | 80.9 (72.0–98.5) | 90.0 (71.8–108.1) | 83.4 (71.0–105.1) |
| Height/length-for-age z-score, median (IQR) | −1.30 (−2.34 to −0.17) | −0.93 (−2.08 to −0.39) | −1.13 (−2.19 to −0.26) | −1.18 (−2.23 to −0.34) |
| Type of TB disease, n (%) | ||||
| PTB only | 16 (80) | 21 (95.5) | 8 (40) | 45 (72.6) |
| EPTB only | 0 (0) | 1 (4.6) | 1 (5) | 2 (3.2) |
| PTB and EPTB | 4 (20) | 0 (0) | 11 (55) | 15 (24.2) |
| EPTB typea, n (% of those with EPTB) | ||||
| abdominal TB | 2 (50) | 1 (100) | 2 (17) | 5 (29) |
| peripheral lymph node TB | 1 (25) | 0 (0) | 1 (8) | 2 (12) |
| pleural effusion | 2 (50) | 0 (0) | 2 (17) | 4 (24) |
| skin | 0 (0) | 0 (0) | 1 (8) | 1 (6) |
| TB meningitis | 1 (25) | 0 (0) | 6 (50) | 7 (41) |
| TB disease classification, n (%) | ||||
| confirmed TB | 5 (25) | 3 (13.6) | 5 (25) | 9 (14.5) |
| probable TB | 15 (75) | 18 (81.8) | 13 (65) | 50 (80.6) |
| possible TB | 0 (0) | 1 (4.5) | 2 (10) | 3 (4.8) |
| Children <5 years of age, n (%) | 16 (80) | 19 (86.4) | 15 (75) | 50 (80.7) |
| Gestational status for children <5 years of age at enrolment | ||||
| number of pre-term births (%) | 4 (25) | 4 (21.1) | 3 (20) | 11 (22) |
| number of term births (%) | 7 (43.8) | 13 (68.4) | 10 (66.7) | 30 (60) |
| number unknown (%) | 5 (31.3) | 2 (10.5) | 2 (13.3) | 9 (18) |
| Duration on rifampicin (days), median (IQR)b | 17.0 (12.5–26.5) | 26.0 (18.0–27.0) | 32.5 (22.0–38.0) | 25.5 (16.0–30.0) |
EPTB, extrapulmonary TB.
a
One child in cohort 1 with EPTB had TB meningitis, abdominal TB and a pleural effusion, all others had only one form of EPTB.
b
Median duration on rifampicin calculated from the date of starting TB treatment until the date of starting study doses of rifampicin.