Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Patients

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    54
  • sponsor
    Shionogi
Updated on 15 December 2021
sepsis
pneumonia
antibiotic therapy
antibiotics
renal function
bacterial infection
prematurity
cefiderocol

Summary

The primary objectives of this study are:

  • To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric patients 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 patients 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 patients 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 patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections

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 patients.

The single-dose phase will include 4 separate cohorts of patients, 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.

Details
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
Treatment Standard of Care, Cefiderocol
Clinical Study IdentifierNCT04335539
SponsorShionogi
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject's parent(s) or legally authorized representative (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 boards/independent ethics committees [IRB's/IEC's] 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 single-dose phase. Hospitalized subject is 3 months to < 12 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Premature babies will not be restricted, but the subject must have an adjusted or postnatal age of 3 months
Subject has a suspected or confirmed infection (including but not limited to cUTI, cIAI, pneumonia [including HAP/VAP], sepsis, or BSI) 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 β-lactam antibiotic (Note: for β-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 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 m² at Screening
Multiple-dose phase: Subject has an eGFR (based on Schwartz equation if ≥ 3
months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to <
years of age) of < 15 mL/min/1.73 m² 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 has 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note