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

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