Study of cefiderocol or standard of care for paediatric patients with confirmed or suspected Gram-negative bacterial infections receiving a single dose and paediatric patents with confirmed or suspected complicated urinary tract infections receiving multiple doses to assess the safety, tolerability and exposure of cefiderocol.

Phase 1

• Conditions: Single dose: Pneumonia, cUTI, complicated intra-abdominal infections [cIAI], hospital acquired pneumonia [HAP]/ventilator-acquired pneumonia [VAP], and sepsis or bloodstream infections [BSI]).Multiple dose: cUTI; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10003997Term: BacteraemiaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002121-30-CZ
• Lead Sponsor: Shionogi B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-18
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Subject’s parent(s) or legally authorized representative (LAR) provides written
informed consent in accordance with regional- and country-specific laws and
regulations
2. 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)
3. 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. Premature babies will not be restricted, but the subject must have an adjusted or postnatal age of 3 months.
4. Single-dose phase: Subject has a suspected or confirmed infection (including but
not limited to cUTI, cIAI, pneumonia, HAP/VAP, sepsis, or BSI) that requires
hospitalization for treatment with IV antibiotics
Multiple-dose phase: Subject has a suspected or confirmed cUTI that requires
hospitalization for treatment with IV antibiotics
5. If subject is a 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 85
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject has a documented history of any hypersensitivity or allergic reaction to
any ß-lactam antibiotic (Note: for ß-lactams, a history of a mild rash followed by
uneventful re-exposure is not a contraindication to enrollment)
2. Multiple-dose only: Subject has an infection caused only by a confirmed
Gram-positive pathogen
3. 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)
4. Subject has cystic fibrosis
5. Single-dose phase: Subject has moderate or severe renal impairment based on
estimated glomerular filtration rate (eGFR) (based on modified Bedside Schwartz
equation [2009]) of < 60 mL/min/1.73 m2 at Screening
Multiple-dose phase: Subject has an eGFR (based on modified Bedside Schwartz
equation [2009]) of < 15 mL/min/1.73 m2 at Screening
6. Subject has end-stage renal disease (ESRD), is on hemodialysis (HD), or
receiving continuous venovenous hemofiltration (CVVH)
7. Subject has experienced shock in the prior month or is in shock at the time of Screening
8. Subject has severe neutropenia or is severely immunocompromised
9. Subject has multiorgan failure
10. Subjects with a life expectancy of < 30 days due to severity of a concurrent illness
11. Subject is a female who has a positive pregnancy test at Screening
12. Subject is a female who is breastfeeding
13. Subject has received any other investigational medicinal product (IMP) within
30 days
14. 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
15. Subject is receiving vasopressor therapy at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified