Table 1. Baseline Data.
| SSG | PM | SSG & PM | ||
| N = 386 | N = 205 | N = 381 | ||
| Centre | Ethiopia: Gondar, n (%) | 60 (15.5) | 15 (7.3) | 60 (15.8) |
| Ethiopia: Arba Minch, n (%) | 45 (11.7) | 15 (7.3) | 45 (11.8) | |
| Kenya: KEMRI, n (%) | 71 (18.4) | 35 (17.1) | 70 (18.4) | |
| Sudan: Um el Kher, n (%) | 30 (7.8) | - | 30 (7.9) | |
| Sudan: Kassab, n (%) | 167 (43.3) | 140 (68.3) | 165 (43.2) | |
| Uganda: Amudat, n (%) | 13 (3.4) | - | 11 (2.9) | |
| Age | Mean (SD) | 15.3 (9.3) | 15.3 (9.9) | 16.1 (9.4) |
| Age 4–17 yearsa, n (%) | 259 (67.1) | 143 (69.8) | 246 (64.6) | |
| Age ≥18 yearsa, n (%) | 127 (32.9) | 62 (30.2) | 135 (35.4) | |
| Sex | Female, n (%) | 105 (27.2) | 80 (39.4) | 108 (28.4) |
| Male, n (%) | 281 (72.8) | 125 (61.0) | 273 (71.6) | |
| Anthropometryb | Weight (Kg) | 33.5 (14.5) | 33.1 (15.5) | 34.2 (14.7) |
| Height (m) | 1.4 (0.2) | 1.4 (0.2) | 1.5 (0.2) | |
| Vital Signsb | Body temperature (°C) | 38.1 (1.1) | 38.4 (1.0) | 38.2 (1.1) |
| Heart Rate (beats/min) | 108.2 (16.1) | 111.7 (14.4) | 107.3 (15.9) | |
| Systolic BP (mm Hg) | 96.3 (11.2) | 96.1 (10.4) | 97.3 (11.1) | |
| Diastolic BP (mm Hg) | 61.5 (8.4) | 59.8 (7.9) | 61.6 (8.1) | |
| Organ Sizeb | Spleen Size (cm) | 8.1 (5.0) | 7.7 (5.0) | 8.0 (4.8) |
| Liver Size (cm) | 3.0 (2.6) | 2.8 (2.7) | 3.0 (2.6) | |
| Nutritional Statusc | Severely underweight, n (%) | 61 (15.8) | 60 (29.3) | 105 (27.5) |
| Underweight, n (%) | 167 (43.3) | 62 (30.2) | 140 (36.8) | |
| Normal, n (%) | 156 (40.4) | 78 (38.6) | 134 (35.2) | |
| Obese/overweight, n (%) | 2 (0.5) | 4 (2.0) | 2 (0.5) | |
| HIV Statusd | HIV-positive, n (%) | 5 (1.3) | 0 (0) | 9 (2.4) |
SSG = sodium stibogluconate (20 mg/kg/day for 30 days); PM = paromomycin sulphate (20 mg/kg/day for 21 days); SSG & PM Combination treatment (SSG at 20 mg/kg/day plus PM at 15 mg/kg/day for 17 days);
a
Patients 4–17 years old were classified as children and patients 18–60 years old were classified as adults.
b
These are presented as mean (SD).
c
Classification based on World Health Organization child growth standards in patients ≤19 years or using body mass index in those ≥20 years.
d
340 out of 386, 203 out of 205, and 335 out of 381 patients were tested for HIV in the SSG, PM and SSG & PM arms respectively.