A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

Exclusion Criteria

• •1. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
• •2. Life expectancy of \< 72 hours after enrollment
• •3. Urine output \< 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
• •4. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1
• •5. Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles\[μmol\]/liter \[L\]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
• •6. Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
• •7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
• •8. Receiving renal replacement therapy
• •9. Received any other investigational medicinal product within 30 days of study drug administration
• •10. Receiving treatment with a vasopressor at Screening
• •11. Has a confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection
• •12. Anticipated need for antibacterial therapy longer than 14 days (example , osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram-positive organisms or multidrug resistant Gram-negative organisms
• •13. Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid