Skip to main content

Advertisement

Table 4 Primary and secondary outcomes in enrolled infants–per-protocol analysis

From: Simplified antibiotic regimens for treating neonates and young infants with severe infections in the Democratic Republic of Congo: a comparative efficacy trial

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
  1. aRegimen A: IM Gentamicin and IM Penicillin × 7 days; Regimen B: IM Gentamicin and oral amoxicillin × 7 days; Regimen C: IM Gentamicin × 7 days and IM Penicillin × 2 days then oral amoxicillin × 5 days; Regimen D: IM Gentamicin × 2 days and oral amoxicillin × 7 days