Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

Inclusion Criteria: * Male or female ≥ 18 years of age * Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture obtained within the 72 h prior to randomization * At least one of the following signs or symptoms of bacteremia: 1. fever (e.g.≥ 38 °C/100.4 °F measured orally) 2. white blood cell count \> 10,000 or \< 4,000 cells/µL, or \> 10% immature neutrophils (bands) 3. tachycardia (heart rate \> 90 bpm) 4. hypotension (systolic blood pressure \< 90 mmHg) * At least one of the following: 1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis 2. Persistent SAB 3. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria 4. Other forms of complicated SAB 5. Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis) 6. Epidural or cerebral abscess * Other inclusion criteria have been applied Exclusion Criteria: * Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; Exception: Documented failure of bloodstream clearance * Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam * Left-sided infective endocarditis * Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices * Community- or hospital-acquired pneumonia * Opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active * Requirement for continuous renal-replacement therapy * Women who are pregnant or nursing * Other exclusion criteria have been applied