Table 4.
Clinical Improvement at Day 4 (Intent-to-Treat and Clinically Evaluable Analysis Sets) in Patients With Hospital-Acquired Pneumonia (Excluding Ventilator-Associated Pneumonia)
| Analysis Set Group | Ceftobiprole |
Ceftazidime/Linezolid |
||||
|---|---|---|---|---|---|---|
| No. | n (%) | No. | n (%) | Difference (%)a | (95% CI)b | |
| ITT | ||||||
| HAP (excluding VAP) | 287 | 221 (77.0) | 284 | 214 (75.4) | 1.7 | (−5.3 to 8.6) |
| Any valid gram-positive | 85 | 69 (81.2) | 102 | 75 (73.5) | 7.6 | (−4.3 to 19.6) |
| Any Staphylococcus aureus | 55 | 45 (81.8) | 76 | 55 (72.4) | 9.4 | (−4.9 to 23.8) |
| Any MRSA | 28 | 22 (78.6) | 32 | 19 (59.4) | 19.2 | (−3.6 to 42.0) |
| Clinically evaluable | ||||||
| HAP (excluding VAP) | 198 | 172 (86.9) | 185 | 145 (78.4) | 8.5 | (.9–16.1) |
| Any valid gram-positive | 61 | 53 (86.9) | 69 | 51 (73.9) | 13.0 | (−.4 to 26.4) |
| Any S. aureus | 39 | 36 (92.3) | 49 | 35 (71.4) | 20.9 | (5.7–36.0) |
| Any MRSA | 19 | 18 (94.7) | 19 | 10 (52.6) | 42.1 | (17.5–66.7) |
Clinical improvement was assessed by the investigator. All categories include monomicrobial and polymicrobial infections.
Abbreviations: CI, confidence interval; HAP, hospital-acquired pneumonia; ITT, intent-to-treat; MRSA, methicillin-resistant Staphylococcus aureus; n, number of patients with clinical improvement at Day 4; VAP, ventilator-associated pneumonia.
a Difference for ceftobiprole minus ceftazidime/linezolid.
b Two-sided 95% CI is based on the normal approximation to the difference of the 2 proportions.