Baseline Characteristics of the Safety Population of the Fosmidomycin–Piperaquine Trial in Adults and Children in Gabon
| Characteristic . | Patients Aged >14 Years (n = 10) . | Patients Aged 5–14 Years (n = 40) . | Patients Aged 1–5 Years (n = 50)a . | Total (n = 100) . |
|---|---|---|---|---|
| Age, y | ||||
| Median (IQR) | 22.5 (19.0–27.0) | 11.5 (10.0–13.0) | 4.1 (3.1–5.0) | 5.9 (4.1–12.0) |
| Gender Male/Female | 8/2 | 14/26 | 34/16 | 56/44 |
| Weight, kg | ||||
| Median (IQR) | 66.0 (53.0–69.0) | 34.2 (29.8–39.8) | 15.0 (12.9–17.0) | 20.2 (15.0–36.2) |
| Body mass index, kg/m2 | ||||
| Median (IQR) | 23.1 (21.8–23.9) | 16.6 (15.2–18.0) | 15.2 (14.5–16.0) | 16.5 (15.0–17.5) |
| Initial parasite count, per µL | ||||
| Geometric mean (95% CI) | 46.8 (20.8–105.4) | 6031 (3907.2–9310.5) | 6625 (4160.5–10549.5) | 4046 (2687.5–6091.5) |
| Proportions with gametocytes on day 0 | ||||
| n/N (%; 95% CI) | 1/10 (10; 0.2–44.5) | 0/40 (0; 0.0–0.9) | 4/50 (8; 2.2–19.2) | 5/100 (5; 1.6–11.2) |
| Axillary temperature, °C | ||||
| Median (range) | 36.03 (35.3–36.6) | 36.6 (34.6–40.2) | 36.6 (34.7–39.1) | 36.6 (34.6–40.2) |
| Hemoglobin value, g/dL | ||||
| Mean (SD) | 11.7 (2.2) | 10.2 (1.3) | 8.7 (1.0) | 9.6 (1.6) |
| White blood cell count, ×103/mm3 | ||||
| Mean (SD) | 7.6 (2.6) | 7.6 (2.1) | 8.9 (2.3) | 8.3 (2.3) |
| Platelet count, ×103/mm3 | ||||
| Mean (SD) | 239 (116.9) | 194 (87.6) | 198 (78.6) | 200 (86.6) |
| Characteristic . | Patients Aged >14 Years (n = 10) . | Patients Aged 5–14 Years (n = 40) . | Patients Aged 1–5 Years (n = 50)a . | Total (n = 100) . |
|---|---|---|---|---|
| Age, y | ||||
| Median (IQR) | 22.5 (19.0–27.0) | 11.5 (10.0–13.0) | 4.1 (3.1–5.0) | 5.9 (4.1–12.0) |
| Gender Male/Female | 8/2 | 14/26 | 34/16 | 56/44 |
| Weight, kg | ||||
| Median (IQR) | 66.0 (53.0–69.0) | 34.2 (29.8–39.8) | 15.0 (12.9–17.0) | 20.2 (15.0–36.2) |
| Body mass index, kg/m2 | ||||
| Median (IQR) | 23.1 (21.8–23.9) | 16.6 (15.2–18.0) | 15.2 (14.5–16.0) | 16.5 (15.0–17.5) |
| Initial parasite count, per µL | ||||
| Geometric mean (95% CI) | 46.8 (20.8–105.4) | 6031 (3907.2–9310.5) | 6625 (4160.5–10549.5) | 4046 (2687.5–6091.5) |
| Proportions with gametocytes on day 0 | ||||
| n/N (%; 95% CI) | 1/10 (10; 0.2–44.5) | 0/40 (0; 0.0–0.9) | 4/50 (8; 2.2–19.2) | 5/100 (5; 1.6–11.2) |
| Axillary temperature, °C | ||||
| Median (range) | 36.03 (35.3–36.6) | 36.6 (34.6–40.2) | 36.6 (34.7–39.1) | 36.6 (34.6–40.2) |
| Hemoglobin value, g/dL | ||||
| Mean (SD) | 11.7 (2.2) | 10.2 (1.3) | 8.7 (1.0) | 9.6 (1.6) |
| White blood cell count, ×103/mm3 | ||||
| Mean (SD) | 7.6 (2.6) | 7.6 (2.1) | 8.9 (2.3) | 8.3 (2.3) |
| Platelet count, ×103/mm3 | ||||
| Mean (SD) | 239 (116.9) | 194 (87.6) | 198 (78.6) | 200 (86.6) |
Abbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation.
aIncluding 11 children aged <3 years.
Baseline Characteristics of the Safety Population of the Fosmidomycin–Piperaquine Trial in Adults and Children in Gabon
| Characteristic . | Patients Aged >14 Years (n = 10) . | Patients Aged 5–14 Years (n = 40) . | Patients Aged 1–5 Years (n = 50)a . | Total (n = 100) . |
|---|---|---|---|---|
| Age, y | ||||
| Median (IQR) | 22.5 (19.0–27.0) | 11.5 (10.0–13.0) | 4.1 (3.1–5.0) | 5.9 (4.1–12.0) |
| Gender Male/Female | 8/2 | 14/26 | 34/16 | 56/44 |
| Weight, kg | ||||
| Median (IQR) | 66.0 (53.0–69.0) | 34.2 (29.8–39.8) | 15.0 (12.9–17.0) | 20.2 (15.0–36.2) |
| Body mass index, kg/m2 | ||||
| Median (IQR) | 23.1 (21.8–23.9) | 16.6 (15.2–18.0) | 15.2 (14.5–16.0) | 16.5 (15.0–17.5) |
| Initial parasite count, per µL | ||||
| Geometric mean (95% CI) | 46.8 (20.8–105.4) | 6031 (3907.2–9310.5) | 6625 (4160.5–10549.5) | 4046 (2687.5–6091.5) |
| Proportions with gametocytes on day 0 | ||||
| n/N (%; 95% CI) | 1/10 (10; 0.2–44.5) | 0/40 (0; 0.0–0.9) | 4/50 (8; 2.2–19.2) | 5/100 (5; 1.6–11.2) |
| Axillary temperature, °C | ||||
| Median (range) | 36.03 (35.3–36.6) | 36.6 (34.6–40.2) | 36.6 (34.7–39.1) | 36.6 (34.6–40.2) |
| Hemoglobin value, g/dL | ||||
| Mean (SD) | 11.7 (2.2) | 10.2 (1.3) | 8.7 (1.0) | 9.6 (1.6) |
| White blood cell count, ×103/mm3 | ||||
| Mean (SD) | 7.6 (2.6) | 7.6 (2.1) | 8.9 (2.3) | 8.3 (2.3) |
| Platelet count, ×103/mm3 | ||||
| Mean (SD) | 239 (116.9) | 194 (87.6) | 198 (78.6) | 200 (86.6) |
| Characteristic . | Patients Aged >14 Years (n = 10) . | Patients Aged 5–14 Years (n = 40) . | Patients Aged 1–5 Years (n = 50)a . | Total (n = 100) . |
|---|---|---|---|---|
| Age, y | ||||
| Median (IQR) | 22.5 (19.0–27.0) | 11.5 (10.0–13.0) | 4.1 (3.1–5.0) | 5.9 (4.1–12.0) |
| Gender Male/Female | 8/2 | 14/26 | 34/16 | 56/44 |
| Weight, kg | ||||
| Median (IQR) | 66.0 (53.0–69.0) | 34.2 (29.8–39.8) | 15.0 (12.9–17.0) | 20.2 (15.0–36.2) |
| Body mass index, kg/m2 | ||||
| Median (IQR) | 23.1 (21.8–23.9) | 16.6 (15.2–18.0) | 15.2 (14.5–16.0) | 16.5 (15.0–17.5) |
| Initial parasite count, per µL | ||||
| Geometric mean (95% CI) | 46.8 (20.8–105.4) | 6031 (3907.2–9310.5) | 6625 (4160.5–10549.5) | 4046 (2687.5–6091.5) |
| Proportions with gametocytes on day 0 | ||||
| n/N (%; 95% CI) | 1/10 (10; 0.2–44.5) | 0/40 (0; 0.0–0.9) | 4/50 (8; 2.2–19.2) | 5/100 (5; 1.6–11.2) |
| Axillary temperature, °C | ||||
| Median (range) | 36.03 (35.3–36.6) | 36.6 (34.6–40.2) | 36.6 (34.7–39.1) | 36.6 (34.6–40.2) |
| Hemoglobin value, g/dL | ||||
| Mean (SD) | 11.7 (2.2) | 10.2 (1.3) | 8.7 (1.0) | 9.6 (1.6) |
| White blood cell count, ×103/mm3 | ||||
| Mean (SD) | 7.6 (2.6) | 7.6 (2.1) | 8.9 (2.3) | 8.3 (2.3) |
| Platelet count, ×103/mm3 | ||||
| Mean (SD) | 239 (116.9) | 194 (87.6) | 198 (78.6) | 200 (86.6) |
Abbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation.
aIncluding 11 children aged <3 years.
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