Randomized | Difference (90% CI) | Non-inferiority test P value | Not randomized population | ||
---|---|---|---|---|---|
Antibiotic treatment for 7 days | Antibiotic treatment for 14 days | ||||
Intention-to-treat population | (n = 94) | (n = 99) | |||
Short-term efficacya | (n = 94) | (n = 99) | (n = 119) | ||
Clinical cureb | 85 (90.4%) | 94 (94.9%) | –4.5% (–10.7 to 1.7) | 0.072 | 101 (84.9%) |
Bacteriologic curec | 86/93 (92.5%) | 89/92 (96.7%) | –4.3% (–9.7 to 1.2) | 0.041 | 94/109 (86.2%) |
Cumulative efficacyd | (n = 94) | (n = 94) | (n = 116) | ||
Clinical cureb | 87 (92.6%) | 86 (91.5%) | 1.1% (–5.5 to 7.6) | 0.005 | 88 (75.9%) |
Per-protocol population | (n = 92) | (n = 92) | |||
Short-term efficacya | (n = 92) | (n = 92) | NA | ||
Clinical cureb | 83 (90.2%) | 87 (94.6%) | –4.3% (–10.8 to 2.1) | 0.073 | |
Bacteriologic curec | 84/91 (92.3%) | 83/86 (96.5%) | –4.2% (–9.9 to 1.4) | 0.045 | |
Cumulative efficacyd | (n = 92) | (n = 87) | |||
Clinical cureb | 85 (92.4%) | 79 (90.8%) | 1.6% (–5.3 to 8.4) | 0.005 |