Table 3.
Clinical cure at TOC visit by high-risk factor and pathogen type (CE population)
| Number of patients (ceftobiprole/ comparator) |
Clinical cure at TOC (%, ceftobiprole/ comparator) |
Treatment difference (%)a | 95% CIb | |
|---|---|---|---|---|
| All patients (CAP) | 231/238 | 86.6/87.4 | −0.8 | −6.9, 5.3 |
| High-risk patients (CAP) | 193/205 | 86.0/86.8 | −0.8 | −7.6, 5.9 |
| Any Gram-positive | 29/40 | 89.7/90.0 | −0.3 | −14.8, 14.1 |
| Any Gram-negative | 34/33 | 82.4/90.9 | −8.6 | −24.7, 7.6 |
| Any S. pneumoniae | 26/33 | 92.3/90.9 | 1.4 | −12.8, 15.6 |
| PORT ≥ III | 126/117 | 86.5/86.3 | 0.2 | −8.4, 8.8 |
| PORT ≥ IV | 51/58 | 90.2/84.5 | 5.7 | −6.7, 18.1 |
| Sepsis | 123/135 | 84.6/86.7 | −2.1 | −10.7, 6.5 |
| Age ≥ 75 years | 39/50 | 92.3/86.0 | 6.3 | −6.4, 19.1 |
| COPD | 51/59 | 86.3/86.4 | −0.2 | −13.0, 12.7 |
| ICU | 25/26 | 72.0/61.5 | 10.5 | −15.2, 36.1 |
| All patients (HAP, excl. VAP) | 198/185 | 77.8/76.2 | 1.6 | −6.9, 10.0 |
| High-risk patients (HAP, excl. VAP) | 169/138 | 75.7/71.7 | 4.0 | −5.9, 13.9 |
| Any Gram-positive | 52/53 | 69.2/69.8 | −2.5 | −19.9, 15.0 |
| Any Gram-negative | 65/60 | 67.7/73.3 | −5.6 | −21.6, 10.3 |
| Mixed/polymicrobial | 29/35 | 62.1/68.6 | −6.5 | −29.9, 16.9 |
| Any S. aureus | 35/38 | 68.6/71.1 | −2.5 | − 23.6, 18.6 |
| APACHE score ≥ 15 | 67/59 | 68.7/64.4 | 4.2 | −12.3, 20.8 |
| >10 comorbidities | 63/61 | 73.0/67.2 | 5.8 | −10.3, 21.9 |
| Mechanical ventilation | 38/37 | 55.3/40.5 | 14.7 | −7.6, 37.1 |
| Age ≥ 75 years | 59/54 | 72.9/77.8 | −4.9 | −20.8, 11.0 |
| COPD | 55/39 | 83.6/76.9 | 6.7 | −9.7, 23.2 |
| ICU | 73/59 | 69.9/66.1 | 3.8 | −12.3, 19.8 |
aBetween treatment difference calculated as ceftobiprole minus ceftriaxone ± linezolid for patients with CAP, and ceftobiprole minus ceftazidime plus linezolid for patients with HAP (excluding VAP)
bTwo-sided 95% CI is based on a normal approximation to the difference of the two proportions
APACHE Acute Physiology and Chronic Health Evaluation, CAP community-acquired pneumonia, CE clinically evaluable, CI confidence interval, COPD chronic obstructive pulmonary disease, HAP hospital-acquired pneumonia, ICU intensive care unit, MRSA methicillin-resistant Staphylococcus aureus, PORT Patient Outcome Research Team, TOC test-of-cure, VAP, ventilator-associated pneumonia