NCT04335539

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

A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (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 and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections

Detailed description

This is a multicenter, single-arm, open-label, single- and multiple-dose study to assess the safety, tolerability, and PK of cefiderocol in hospitalized paediatric participants. The single-dose phase will include 4 separate cohorts of participants, grouped according to age range: * Cohort 1: 12 to \< 18 years * Cohort 2: 6 to \< 12 years * Cohort 3: 2 to \< 6 years * Cohort 4: 3 months to \< 2 years Cohorts 1, 2, and 3 in the single-dose phase will be initiated in parallel. Cohort 4 will begin after safety and PK data from at least 6 participants from the single-dose Cohorts 1, 2, and 3 (with a minimum of 3 participants from Cohort 3) have been assessed. The multiple-dose phase will include 3 cohorts according to age range (Cohorts 2, 3, and 4) and will begin after safety and PK data from 6 participants in the corresponding single-dose cohort have been assessed.

Conditions

• Gram-negative Bacterial Infections
• Bloodstream Infections (BSI)
• Complicated Intra-abdominal Infection (cIAI)
• Hospital Acquired Pneumonia (HAP)
• Ventilator-acquired Pneumonia
• Complicated Urinary Tract Infection (cUTI)
• Sepsis

Interventions

Type	Name	Description
DRUG	Cefiderocol	Administered intravenously over 3 hours
DRUG	Standard of Care	Standard of care antibiotics 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: 2020-08-21
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2020-04-06
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

23 sites across 9 countries: Belgium, Estonia, Georgia, Hungary, Latvia, Russia, Spain, Thailand, Ukraine

Regulatory

• FDA-regulated drug study