NCT04215991

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

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).

Detailed description

This study consists of a nonrandomized single-dose phase in children aged 3 months to less than 12 years with suspected or confirmed aerobic Gram-negative bacterial infections and a randomized multiple-dose, active-comparator standard of care (SOC) phase in children aged 3 months to less than 18 years with cUTI, HABP, or VABP to assess the PK, safety, and tolerability of cefiderocol in hospitalized participants requiring systemic antibiotics for an expected 5 to 14 days.

Conditions

• Gram-negative Bacterial Infections
• Hospital Acquired Bacterial Pneumonia (HABP)
• Complicated Urinary Tract Infection (cUTI)
• Ventilator Associated Bacterial Pneumonia (VABP)

Interventions

Type	Name	Description
DRUG	Cefiderocol	Administered intravenously over 3 hours
DRUG	Standard of Care	Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards.

Timeline

• Start date: 2020-02-19
• Primary completion: 2024-09-17
• Completion: 2024-09-17
• First posted: 2020-01-02
• Last updated: 2025-05-25

Locations

25 sites across 10 countries: United States, Australia, Georgia, Greece, Lithuania, Mexico, Panama, Philippines, Spain, Ukraine

Regulatory

• FDA-regulated drug study