A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Exclusion Criteria

• •1. Participant has a documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment).
• •2. Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen.
• •3. Participant has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
• •4. Participant has cystic fibrosis.
• •5. Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on Schwartz equation if ≥ 3 months to \< 1 year of age and modified Bedside Schwartz equation if ≥ 1 to \< 18 years of age) of \< 60 milliliter (mL) per minute (min)/1.73 \^2² at Screening.
• •Multiple-dose phase: Participant has an eGFR (based on Schwartz equation if ≥ 3 months to \< 1 year of age and modified Bedside Schwartz equation if ≥ 1 to \< 18 years of age) of \< 15 mL/min/1.73 \^2² at Screening.
• •6. Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
• •7. Participant has experienced shock in the prior month or is in shock at the time of Screening.
• •8. Participant has severe neutropenia or is severely immunocompromised.
• •9. Participant has multiorgan failure.
• •10. Participant has a life expectancy of \< 30 days due to severity of a concurrent illness.
• •11. Participant is a female who has a positive pregnancy test at Screening.
• •12. Participant is a female who is breastfeeding.
• •13. Participant has received any other investigational medicinal product (IMP) within 30 days.
• •14. Participant has 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, including acute trauma to the pelvis or urinary tract.
• •15. Participant is receiving vasopressor therapy at Screening.