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 culture
obtained within the 72 h prior to randomization

- At least two of the following signs or symptoms of bacteremia:

1. fever ≥ 38°C/100.4°F

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

- Other inclusion criteria may apply

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 may apply