Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
Condition: Staphylococcus Aureus Bacteremia
MeSH terms: Staphylococcal Infections; Bacteremia
Intervention: Ceftobiprole medocaril; Daptomycin
Intervention description: Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion; Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam
Intervention MeSH terms: Daptomycin; Ceftobiprole; Ceftobiprole medocaril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 390.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ceftobiprole, daptomycin, Staphylococcus aureus; Bacteremia, bloodstream infection

Summary:

      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).
    

Eligibility criteria:

        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