Table 1.
Demographic and Clinical Data of Child Participants of the Linezolid Pharmacokinetic and Safety Studies Included in the Current Study
| Characteristic | South Africa | India | MDRPK1 and MDRPK2 Studies, South Africa | Total |
|---|---|---|---|---|
| Participants | 3 | 25 | 84 | 112 |
| Linezolid exposure groups, n | ||||
| No long-term linezolid | ||||
| None | 0 | 0 | 12 | 12 |
| Single dose | 0 | 0 | 40 | 40 |
| Long-term linezolid | ||||
| Multiple dose | 3 | 25 | 32 | 60 |
| Linezolid concentration, n | ||||
| Participants with concentration data, n | 0 | 0 | 72 | 72 |
| Total concentration samples, n | 0 | 0 | 329 | 329 |
| Below the limit of quantification, n (%) | 0 | 0 | 46 (14) | 46 (14) |
| Concentration, median (range) in mg/L | 0 | 0 | 7.5 (0.6–28.8) | 7.5 (0.6–28.8) |
| Duration on linezolid, median (range), m | 3.1 (3.1–6.4) | 24 (0.1 -25.6) | 18 (3.1–22.2) | 18.2 (0.1–25.6) |
| Baseline hemoglobin, median (interquartile range), g/dL | 12.2 (11.7–12.7) | 10.7 (9.2–12.0) | 11.6 (10.8–12.7) | 11.6 (10.4–12.6) |
| Sex, n (%) | ||||
| Female | 2 (66.6) | 18 (72.0) | 44 (52.4) | 64 (57.1) |
| Male | 1 (33.3) | 7 (28.0) | 40 (47.6) | 48 (43.9) |
| Human immunodeficiency virus–positive, n (%) | 0 | 0 | 2 (2.4) | 2 (1.8) |
| Age, median (range), y | 6.7 (2.1–9.6) | 14.0 (8.0–15) | 4.3 (0.3–16.3) | 7.2 (0.3–16.3) |
| Weight, median (range), kg | 19.0 (13.0–25.0) | 28 (13–56) | 13.0 (6.3–57.6) | 17.8 (6.3–57.6) |
| Dose, median (range), mg/kg | 18.6 (11.3–32.2) | 15.0 (12.2–22.2) | 13.3 (3.4–33.3) | 13.6 (3.4–33.3) |
| Participants with any anemia, n (%) | 0 (0) | 19 (76.0) | 33 (39.3) | 52 (46.4) |
| Anemia events, n | 0 | 50 | 96 | 146 |
| Grade 1 (mild) | 0 | 14 | 48 | 62 |
| Grade 2 (moderate) | 0 | 14 | 25 | 39 |
| Grade 3 (severe) | 0 | 18 | 11 | 29 |
| Grade 4 (potentially life-threatening) | 0 | 4 | 12 | 16 |
Abbreviations: AUC, area under the concentration-time curve; WAZ, Weight-for-age z.