Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Inclusion Criteria:

• Male or female ≥ 18 years of age
• Staphylococcus aureus bacteremia (SAB), based on at least one positive blood cultureobtained 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% immatureneutrophils (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 peritonealdialysis
2. Persistent SAB
3. Definite native-valve right-sided infective endocarditis by Modified Duke'sCriteria
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 antibacterialtreatment 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 thatare known to be non-susceptible to either ceftobiprole or aztreonam
• Left-sided infective endocarditis
• Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automaticimplantable cardioverter-defibrillator, or left-ventricular assist devices
• Community- or hospital-acquired pneumonia
• Opportunistic infections within 30 days prior to randomization, where the underlyingcause of these infections is still active
• Requirement for continuous renal-replacement therapy
• Women who are pregnant or nursing
• Other exclusion criteria have been applied