TABLE 1.
Patients’ characteristics
| Characteristica | Treatment arm |
P valueb
|
||
|---|---|---|---|---|
| 450 mg (10 mg/kg; n = 20) |
900 mg (20 mg/kg; n = 20) |
1,350 mg (30 mg/kg; n = 20) |
||
| Male sex (n [%]) | 12 (60) | 8 (40) | 12 (60) | 0.343 |
| Age (yr) (median [IQR]) | 28 (22.3–45.8) | 29 (21.3–38.3) | 33 (24.3–37.3) | 0.976 |
| Body wt (kg) (median [IQR]) | 45 (40–47.3) | 45 (38.5–50.5) | 48.4 (41.6–54.7) | 0.491 |
| BMI (median [IQR]) | 17.6 (15.4–19) | 18.2 (16–20.4) | 19.1 (16.2–20.2) | 0.396 |
| Temp (°C) (median [IQR]) | 37.2 (36.5–38.2) | 38 (37.2–38.2) | 37.6 (37–38) | 0.162 |
| Chief complaint (n [%]) | ||||
| Lowered consciousness | 17 (85) | 16 (80) | 18 (90) | 0.594 |
| Headache | 19 (33.3) | 19 (33.3) | 19 (33.3) | 0.558 |
| Neck stiffness | 20 (100) | 19 (95) | 15 (75) | 0.401 |
| Cranial nerve palsy | 15 (75) | 15 (75) | 17 (85) | 0.614 |
| Motoric abnormality | 11 (55) | 12 (60) | 13 (65) | 0.642 |
| TBM grade (n [%]) | 0.663 | |||
| 1 | 0 (0.0) | 1 (5.0) | 0 (0) | |
| 2 | 18 (90.0) | 18 (90.0) | 18 (90) | |
| 3 | 2 (10.0) | 1 (5.0) | 2 (10) | |
| HIV positive (n [%]) | 1 (5.0) | 1 (5.0) | 4 (20) | 0.261 |
| GCS (median [IQR]) | 13 (12–14) | 12.5 (11.3–13.8) | 13 (11.3–13.8) | 0.877 |
| Chest X ray, TB (n [%]) | 13 (86.7) | 12 (85.7) | 12 (85.7) | 0.752 |
| CSF baselines (median [IQR]) | ||||
| Leukocytes (cells/µl) | 188 (60.5–413.8) | 245 (98.8–698.8) | 240 (128.3–482.5) | 0.528 |
| PMN (cells/µl) | 30 (18–46) | 29 (13.3–67) | 41 (21.3–65.3) | 0.625 |
| MN (cells/µl) | 70 (54–82) | 71 (33–86.8) | 59 (34.8–78.8) | 0.580 |
| Protein (mg/dl) | 257 (172.7–372.3) | 216.5 (158.8–428) | 169 (116.5–230.8) | 0.057 |
| CSF/blood glucose ratio baseline (median [IQR]) | 0.17 (0.09–0.26) | 0.2 (0.12–0.21) | 0.2 (0.1–0.3) | 0.303 |
| Bacteriologically confirmed TBM (n [%]) | 14 (70) | 14 (70) | 15 (75) | 0.921 |
| Culture positive | 13 (65) | 13 (65) | 14 (70) | 0.928 |
| ZN staining positive | 8 (40) | 4 (20) | 6 (30) | 0.386 |
| Gene Xpert positive | 9 (45) | 8 (40) | 10 (50) | 0.582 |
| Drug administration through NGT on PK1 (n [%]) | 10 (58.8) | 12 (60.0) | 13 (65) | 0.917 |
| Drug administration through NGT on PK2 (n [%]) | 1 (6.7) | 3 (21.4) | 5 (26.3) | 0.33 |
| Dose (median [IQR]) | ||||
| Isoniazid (mg/kg) | 6.7 (6.4–7.5) | 6.7 (6–7.9) | 6.2 (5.5–7.2) | 0.308 |
| Pyrazinamide (mg/kg) | 33.7 (33.3–37.5) | 33.3 (31.6–39.5) | 31.06 (27.4–36) | 0.203 |
| Ethambutol (mg/kg) | 16.8 (16.7–20.1) | 16.7 (15–21.1) | 15.5 (14–18.5) | 0.244 |
| Rifampin (mg/kg) | 10 (9.5–11.3) | 20 (17.8–23.4) | 28 (24.7–32.4) | <0.001 |
a
TB, tuberculosis; IQR, interquartile range; BMI, body mass index; TBM, tuberculous meningitis; GCS, Glasgow coma scale; CSF, cerebrospinal fluid; ZN, Ziehl-Neelsen; NGT, nasogastric tube; PK, pharmacokinetic(s); PMN, polymorphonuclear cells; MN, mononuclear cells.
b
Kruskal-Wallis tests for comparisons of continuous variables, χ2 tests for comparisons of the proportions in categorical variables.