Table 4 Primary and secondary outcomes in enrolled infants–per-protocol analysis
Regimena | A | B | C | D |
|---|---|---|---|---|
Number of infants analyzed | 146 | 135 | 144 | 135 |
Treatment failure n (%) | 17 (11.6%) | 13 (9.6%) | 13 (9.0%) | 9 (6.7%) |
Risk difference % (95% CI) | referent | -2.0 (− 9.2 to 5.2) | -2.6 (−9.6 to 4.4) | -5.0 (−11.7 to 1.7) |
Reason for treatment failure | ||||
Death | 1 (0.7%) | 2 (1.5%) | 6 (4.2%) | 2 (1.5%) |
Appearance of a sign of critical illness | 2 (1.4%) | 2 (1.5%) | 2 (1.4%) | 3 (2.2%) |
Appearance of a new sign of serious infection | 1 (0.7%) | 2 (1.5%) | 2 (1.4%) | 0 |
SAE other than death | 0 | 0 | 0 | 0 |
Hospitalization | 0 | 0 | 0 | 0 |
No improvement in clinical condition by day 4 | 10 (6.8%) | 6 (4.4%) | 1 (0.7%) | 4 (3.0%) |
Reappearance of inclusion sign between days 5–8 | 2 (1.4%) | 1 (0.7%) | 2 (1.4%) | 0 |
Presence of inclusion sign on day 8 | 1 (0.7%) | 0 | 0 | 0 |