A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
Condition: 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
MeSH terms: Infections; Communicable Diseases; Pneumonia; Urinary Tract Infections; Bacterial Infections; Sepsis; Intraabdominal Infections; Healthcare-Associated Pneumonia; Gram-Negative Bacterial Infections; Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Cefiderocol; Standard of Care
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously over 3 hours; 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.
Other intervention name(s): S-649266; Fetroja
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment