Table 3.
Sample size calculation parameters of phase III, community-acquired pneumonia trials
| Antibiotic | Short name of the trial | Publication year | Comparator | Calculated sample size | Included subjects (n) | Assumed cure rate (%) | Observed cure rate: study drug vs comparator (%) | Non-inferiority margin (%) | Observed difference (95% CI) | Power (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ceftaroline | FOCUS 1 [63] | 2011 | Ceftriaxone | 610 | 614 | 90 | 86.6 vs 78.2 | − 10 | 8.4 (1.4 to 15.4) | > 90 |
| Ceftaroline | FOCUS 2 [64] | 2011 | Ceftriaxone | 610 | 627 | 90 | 82.1 vs 77.2 | − 10 | 4.9 (− 2.5 to 12.5) | > 90 |
| Ertapenem | Study 018 [65] | 2002 | Ceftriaxone | 300 | 502 | 90 | 92.4 vs 91.3 | − 10 | 1 (− 4.9 to 7)a | 80 |
| Ertapenem | Study 020 [66] | 2002 | Ceftriaxone | 150 | 364 | > 90 | 92.2 vs 93.6 | − 10 | − 1.4 (− 8.6 to 5.7)a | 97 |
| Lefamulin | LEAP 1 [67] | 2019 | Moxifloxacin | 550 | 551 | 80 | 86.9 vs 89.4 | − 10 | − 2.5 (− 8.4 to 3.4) | 80 |
| Lefamulin | LEAP 2 [68] | 2019 | Moxifloxacin | 738 | 738 | 80 | 89.7 vs 93.6 | − 10 | − 3.9 (− 8.2 to ∞) | 91 |
| Omadacycline | OPTIC [60] | 2019 | Moxifloxacin | 750 | 774 | 79 | 81.1 vs 82.7 | − 10 | − 1.6 (− 7.1 to 3.8) | 92 |
| Telithromycin | Study 3000 [69] | 2002 | No comparator | n/a | 240 | n/a | 93.6 | n/a | n/a | n/a |
| Telithromycin | Study 3001 [70] | 2002 | Amoxicillin | 240 | 404 | 85 | 94.6 vs 90.1 | − 15 | 4.5 (− 1.2 to 11.1) | 90 |
| Telithromycin | Study 3006 [71] | 2004 | Clarithromycin | 240 | 416 | 85 | 88.3 vs 88.5 | − 15 | − 0.2 (− 7.8 to 7.5) | 90 |
| Telithromycin | Study 3009 [72] | 2003 | Trovafloxacin | n/a | 204 | n/a | 90 vs 94.2 | − 15 | − 4.2 (− 13.6 to 5.2) | n/a |
Italicized column show pre-defined parameters of the statistical analysis. The lower limits of the 95% CI are in bold because they indicate whether non-inferiority could be shown or not
CI confidence interval, n/a not available
aDifference adjusted (weighted) for strata