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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

Primary Purpose

Gram-Negative Bacterial Infections

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cefiderocol
Standard of Care
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Negative Bacterial Infections focused on measuring Complicated urinary tract infection (cUTI), Complicated intra-abdominal infection (cIAI), Hospital-acquired bacterial pneumonia (HABP), Ventilator-associated (VABP), Bloodstream infection (BSI)/sepsis

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

Eligibility Criteria: Key Inclusion Criteria: Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements Hospitalized infants from birth to < 3 months (< 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 ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg) 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 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 Key Exclusion Criteria: Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic Life expectancy of < 72 hours after enrollment Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1 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 Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value 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 Receiving renal replacement therapy Received any other investigational medicinal product within 30 days of study drug administration Receiving treatment with a vasopressor at Screening 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 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 Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) 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 Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Single-Dose Cefiderocol

    Multiple-Dose Cefiderocol

    Arm Description

    Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics

    Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics

    Outcomes

    Primary Outcome Measures

    Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
    Cmax After a Minimum of 4 Doses of Cefiderocol
    Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
    Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
    Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
    Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol

    Secondary Outcome Measures

    Number of Participants With Adverse Events (AEs)

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Shionogi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086626
    Brief Title
    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
    Official Title
    A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    April 25, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shionogi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gram-Negative Bacterial Infections
    Keywords
    Complicated urinary tract infection (cUTI), Complicated intra-abdominal infection (cIAI), Hospital-acquired bacterial pneumonia (HABP), Ventilator-associated (VABP), Bloodstream infection (BSI)/sepsis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-Dose Cefiderocol
    Arm Type
    Experimental
    Arm Description
    Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics
    Arm Title
    Multiple-Dose Cefiderocol
    Arm Type
    Experimental
    Arm Description
    Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics
    Intervention Type
    Drug
    Intervention Name(s)
    Cefiderocol
    Other Intervention Name(s)
    S-649266
    Intervention Description
    Administered via intravenous (IV) infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Antibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards
    Primary Outcome Measure Information:
    Title
    Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
    Time Frame
    Up to 8 hours postdose
    Title
    Cmax After a Minimum of 4 Doses of Cefiderocol
    Time Frame
    Up to 8 hours postdose
    Title
    Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
    Time Frame
    Up to 8 hours postdose
    Title
    Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
    Time Frame
    Up to 3 hours
    Title
    Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
    Time Frame
    Up to 8 hours postdose
    Title
    Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
    Time Frame
    Up to 8 hours postdose
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events (AEs)
    Time Frame
    Up to 28 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Eligibility Criteria: Key Inclusion Criteria: Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements Hospitalized infants from birth to < 3 months (< 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 ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg) 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 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 Key Exclusion Criteria: Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic Life expectancy of < 72 hours after enrollment Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1 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 Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value 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 Receiving renal replacement therapy Received any other investigational medicinal product within 30 days of study drug administration Receiving treatment with a vasopressor at Screening 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 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 Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) 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 Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shionogi Clinical Trials Administrator Clinical Support Help Line
    Phone
    1-800-849-9707
    Email
    Shionogiclintrials-admin@shionogi.co.jp
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Shionogi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

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