Baseline characteristics
| SOC (n=59) | SOC-F (n=61) | All (n=120) | P value (SOC vs SOC-F) | |
| Age (days) | 1 (0–4) | 1 (0–3) | 1 (0–3) | |
| Gestational age (weeks) | 38 (37–40) | 40 (38–40) | 39 (38–40) | 0.079 |
| Sex | ||||
| Female | 24 (41) | 24 (39) | 48 (40) | 0.881 |
| Male | 35 (59) | 37 (61) | 72 (60) | |
| Anthropometry | ||||
| Weight (g) | 2700 (2080–3200) | 2800 (2500–3230) | 2750 (2370–3215) | 0.154 |
| Head circumference (cm) | 34.0 (32.5–36.0) | 34.7 (33.6–36.0) | 34.6 (33.0–36.0) | 0.173 |
| Length (cm) | 48.0 (44.4–49.5) | 48.0 (46.0–49.5) | 48.0 (45.0–49.5) | 0.371 |
| Admitted from | ||||
| KCH maternity | 24 (41) | 28 (46) | 52 (43) | 0.846 |
| Other health facility | 20 (34) | 19 (31) | 39 (33) | |
| Home | 15 (25) | 14 (23) | 29 (24) | |
| Clinical symptoms | ||||
| Fever | 21 (36) | 22 (36) | 43 (36) | 0.957 |
| Difficulty in breathing | 39 (66) | 40 (66) | 79 (66) | 0.951 |
| Difficulty feeding | 10 (17) | 11 (18) | 21 (18) | 0.876 |
| Seizures | 8 (14) | 11 (18) | 19 (16) | 0.502 |
| Vomiting | 1 (1.7) | 1 (1.6) | 2 (1.7) | 0.981 |
| Clinical signs | ||||
| Axillary temperature (°C) | 36.8 (36.3–37.4) | 37 (35.7–37.6) | 36.9 (35.9–37.5) | 0.580 |
| Heart rate (bpm) | 147 (136–161) | 147 (138–158) | 147 (138–159) | 0.471 |
| Respiratory rate (bpm) | 54 (45–68) | 56 (48–68) | 56 (48–68) | 0.953 |
| Oxygen saturation (%) | 96 (86–97) | 95 (88–98) | 96 (88–98) | 0.484 |
| Capillary refill time ≥2 s | 12 (20) | 14 (23) | 26 (22) | 0.728 |
| Respiratory distress* | 43 (73) | 37 (61) | 80 (67) | 0.156 |
| Jaundice | 6 (10) | 11 (18) | 17 (14) | 0.217 |
| Skin lesions† | 4 (6.8) | 3 (4.9) | 7 (5.8) | 0.664 |
| Abdominal distension | 5 (8.5) | 1 (1.6) | 6 (5.0) | 0.086 |
| Impaired consciousness‡ | 2 (3.4) | 9 (15) | 11 (9.2) | 0.031 |
| Abnormal posture | 1 (1.7) | 3 (4.9) | 4 (3.3) | 0.223 |
| Abnormal tone | 8 (14) | 13 (21) | 21 (18) | 0.264 |
| Bulging fontanel | ||||
| Agitated | 9 (15) | 11 (18) | 20 (17) | 0.683 |
| Lethargic | 10 (17) | 17 (28) | 27 (23) | 0.152 |
Data are n (%) or median (q25–q75).
*Nasal flaring, lower chest wall indrawing and/or grunting.
†Pustules, vesicles, petechiae and/or cellulitis.
‡Responsive to pain only or unresponsive.
KCH, Kilifi County Hospital; SOC, standard of care; SOC-F, standard of care plus fosfomycin.