A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients from Birth to less than 3 Months of Age with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Phase 2

• Conditions: Aerobic Gram-negative Bacterial Infections; Complicated urinary tract infection (cUTI); Complicated intra-abdominal infection (cIAI); Hospital-acquired bacterial pneumonia (HABP); Ventilator-associated (VABP); Bloodstream infection (BSI)/sepsis

• Registration Number: TCTR20240718005
• Lead Sponsor: Shionogi Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Last Update Posted: 19 August 2024
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
2. Hospitalized infants from birth to less than 3 months (less than 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA equal or greater than 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
3. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
4. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection

Exclusion Criteria

1. Documented history of any moderate or severe hypersensitivity or allergic reaction to any beta-lactam antibiotic
2. Life expectancy of less than 72 hours after enrollment
3. Urine output less than 1.0 milliliter/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, defined as a serum creatinine level greater than 1.5 milligrams per decilieter (133 micromoles/ liter) or an increase of 0.3 mg per dL (17 to 27 micromol/L per day) from a previous lower value
6. Acute kidney injury based on an increase in serum creatinine equal or more than 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 infection (CNS), including suspected CNS infection who do not have a lumbar puncture 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol Up to 8 hours postdose Plasma Concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
umber of Participants With Adverse Events (AEs) Up to 28 days Adverse events will be collected from the time signed informed consent is obtained through the EOS Visit or 28 (+ 7) days after administration of the last dose of the study treatment