A Study of Ceftobiprole Compared With Standard Antibiotic Treatment in Children With Staphylococcus Aureus Bacteremia (SAB) Infection, Including Right-sided Heart Infection

Key Inclusion Criteria:

• Pediatric age from birth to < 18 years old, with body weight ≥ 3.7 kg at the time of consent. Participants in the birth to < 2-year-old cohort should have a gestational age ≥ 37 weeks and postnatal age ≥ 3 days

• Parent(s) or legal guardian(s) have provided documented informed consent, and participant has provided assent as per local standards.

• SAB:

  1. Based on at least one blood culture obtained within 48 hours prior to randomization that is positive for S. aureus
  2. Persistent SAB

Key Exclusion Criteria:

• Receipt of systemic antibacterial treatment for S. aureus infections exceeding 48 hours within the 7 days prior to randomization.
• Infection with S. aureus known or suspected to be non-susceptible to ceftobiprole or available SOC comparator antibiotic options
• Known concomitant bloodstream or non-bloodstream infections with Gram-negative bacteria at screening
• Left-sided IE (known or suspected to be present at the time of randomization)
• Contraindication to the administration of study treatments, including known clinically-relevant hypersensitivity to beta-lactam antibacterials
• High probability of death within 7 days due to the underlying SAB or SAB-associated disease, or high probability of death within 28 days from an unrelated underlying disease
• An absolute neutrophil count of < 0.5 x 10^9/L
• Septic shock or hypotension unresponsive to IV fluids with or without vasopressors for ≥ 4 hours
• SAB in participants with other foreign body material that cannot be removed within 7 days after randomization
• Suspected or confirmed metastatic central nervous system S. aureus infection
• Immunocompromising conditions
• Receipt of systemic steroids (prednisolone ≥ 2 mg/kg per day, or equivalent) or immunosuppressive drugs within 2 weeks prior to screening
• Any severe, acute or chronic medical or psychiatric condition, recent neurological event, or laboratory abnormality that may increase the risk associated with study participation or administration of study treatments, or may interfere with the interpretation of study results, and which, in the judgment of the Investigator, would make the participant inappropriate for entry into this study
• eGFR of < 30 mL/min/1.73 m² for participants < 2 years old and < 15 mL/min/1.73 m² for participants ≥ 2 years old, or, for any age, requirement/anticipated requirement for plasmapheresis, peritoneal dialysis, hemodialysis, venovenous dialysis, continuous renal-replacement therapy (CRRT), or other forms of renal filtration.
• History of seizures other than well-documented febrile seizures of childhood
• Alanine transaminase (ALT) or aspartate transaminase (AST) levels > 5 × the upper limit of normal (ULN), OR total bilirubin > 2 × the ULN (except isolated unconjugated hyperbilirubinemia consistent with Gilbert's syndrome), OR severe hepatic disease classified as Child-Pugh class C