TABLE 1.
Demographics and baseline characteristics: phase I population of children with multidrug-resistant tuberculosis receiving delamanid and an optimized background regimen
| Characteristic | Value for group: |
||||
|---|---|---|---|---|---|
| 12–17 yrs (n = 7) | 6–11 yrs (n = 6) | 3–5 yrs (n = 12) | 0–2 yrs (n = 12) | Total (n = 37) | |
| Age, median yrs (range) | 15.50 (13.3–17.5) | 9.55 (7.3–11.4) | 4.35 (3.1–5.9) | 1.65 (0.7–2.5) | 4.40 (0.7–17.5) |
| Male, n (%) | 4 (57.1) | 2 (33.3) | 6 (50.0) | 6 (50.0) | 18 (48.6) |
| Wt, median kg (range) | 38.5 (34–45) | 25.0 (16–34) | 14.2 (10–19) | 10.1 (6–13) | 14.3 (6–45) |
| Race, n (%) | |||||
| Asian | 7 (100.0) | 4 (66.7) | 8 (66.7) | 6 (50.0) | 25 (67.6) |
| Black | 0 (0.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) | 2 (5.4) |
| Mixed or other | 0 (0.0) | 2 (33.3) | 2 (16.7) | 6 (50.0) | 10 (27.0) |
| MDR-TB diagnostic criteria, n (%) | |||||
| Confirmeda | 6 (86) | 3 (50) | 3 (25) | 3 (25) | 15 (41) |
| Presumptiveb | 1 (14) | 3 (50) | 9 (75) | 9 (75) | 22 (59) |
| Chest radiograph, n (%) | |||||
| Not done | 0 (0.0) | 0 (0.0) | 1 (8.3) | 0 (0.0) | 1 (2.7) |
| Normal | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (2.7) |
| Abnormal | 7 (100.0) | 5 (83.3) | 11 (91.7) | 12 (100.0) | 35 (94.6) |
| Findings on chest radiograph at time of diagnosis consistent with TB, n (%) | 7 (100.0) | 4 (66.7) | 11 (91.7) | 10 (83.3) | 32 (86.5) |
| Site of disease, n (%) | |||||
| Pulmonary only | 7 (100.0) | 2 (33.3) | 7 (58.3) | 10 (83.3) | 26 (70.3) |
| Extrapulmonary only | 0 | 1 (16.7) | 1 (8.3) | 0 (0.0) | 2 (5.4) |
| Both pulmonary and extrapulmonary | 0 | 3 (50.0) | 4 (33.3) | 2 (16.7) | 9 (24.3) |
a
Confirmed diagnosis: a child with laboratory diagnosis of MDR-TB (i.e., culture with a drug susceptibility test and/or rapid testing).
b
Presumptive diagnosis: a child with TB and a recent close contact with MDR-TB, a child who fails to improve while adherent to first-line anti-TB treatment, or a child with an adult source case who is a treatment failure, a retreatment case, or recently died from TB.