Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

Key Inclusion Criteria: * Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study * Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months * Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment * Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line Key Exclusion Criteria: * Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment * Proven ventilator-associated pneumonia * Proven central nervous system infection (e.g., meningitis, brain abscess) * Proven osteomyelitis, infective endocarditis, or necrotizing enterocolitis * Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output \< 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis * Progressively fatal underlying disease, or life expectancy \< 30 days * Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication * Participation in another clinical study with an investigational product within 30 days of enrollment in the current study