Safety Tolerability and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Patients

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    85
  • sponsor
    Shionogi
Updated on 7 August 2021
pneumonia
antibiotics
renal function

Summary

To assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric patients 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP).

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 (SOC) phase in children aged 3 months to less than 18 years with cUTI, HAP, or VAP to assess the PK, safety, and tolerability of cefiderocol in hospitalized patients requiring systemic antibiotics for an expected 5 to 14 days.

Details
Condition Hospital Acquired Pneumonia, gram-negative bacterial infection, Nosocomial Pneumonia, Bacterial Infection, Pneumonia, Ventilator associated pneumonia, Complicated Urinary Tract Infection, Pneumonia (Pediatric), Gram-Negative Bacterial Infections, Bacterial Infections, ventilator-associated pneumonia
Treatment Standard of Care, Cefiderocol
Clinical Study IdentifierNCT04215991
SponsorShionogi
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject's parent(s) or legally authorized representative(s) (LAR) provides written informed consent in accordance with regional- and country-specific laws and regulations
Subject provides written informed assent, when feasible (age of assent to be determined by institutional review board/independent ethics committee [IRBs/IECs] or be consistent with local legal requirements)
Hospitalized subject is 3 months to < 18 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Hospitalized subject is 3 months to < 12 years of age at the time written informed consent/assent is obtained for the single-dose phase
Single-dose phase: Subject has a suspected or confirmed infection type (including but not limited to cUTI, cIAI (including pneumonia, HAP/VAP), and sepsis or BSI) that requires hospitalization for treatment with IV antibiotics
Multiple-dose phase: Subject has a suspected or confirmed cUTI, HAP, or VAP
that requires hospitalization for treatment with IV antibiotics
\. If subject is a sexually active female of childbearing potential and has
reached menarche or Tanner stage 3, subject agrees to use barrier
contraception (including condom, diaphragm, or cervical cap) with spermicide
or agrees to use a highly effective method of contraception (including
contraceptive implant, injectable contraceptive, combination oral
contraceptive, or an intrauterine [IUD] contraceptive device) from Screening
up to 28 days after administration of the last dose of cefiderocol

Exclusion Criteria

Subject has a documented history of any hypersensitivity or allergic reaction to any -lactam antibiotic (Note: for -lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
Multiple-dose only: Subject has an infection caused only by a confirmed Gram-positive pathogen
Subject has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy)
Subject has cystic fibrosis
Single-dose phase: Subject has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on the Schwartz equation if 3 months to < 1 year of age and modified Bedside Schwartz equation if 1 to < 18 years of age) of < 60 mL/min/1.73 m at Screening
Multiple-dose phase: Subject has an eGFR (based on the Schwartz equation if 3
months to < 1 year of age and modified Bedside Schwartz equation if 1 to < 18
years of age) of < 15 mL/min/1.73 m at Screening
\. Subject has end-stage renal disease (ESRD), is on hemodialysis (HD), or
receiving continuous venovenous hemofiltration (CVVH)
\. Subject has experienced shock in the prior month or is in shock at the
time of Screening
\. Subject has severe neutropenia or is severely immunocompromised
\. Subject has multiorgan failure
\. Subjects with a life expectancy of < 30 days due to severity of a
concurrent illness
\. Subject is a female who has a positive pregnancy test at Screening
\. Subject is a female who is breastfeeding
\. Subject has received any other investigational medicinal product (IMP)
within 30 days
\. Subject has any condition or circumstance that, in the opinion of the
investigator, would compromise the safety of the subject or the quality of the
study data, including acute trauma to the pelvis or urinary tract
\. Subject is receiving vasopressor therapy at Screening
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