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

Sepsis Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04335539
• Study type: Interventional
• Source: Shionogi Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 21, 2020
• Completion date: February 6, 2023