EUCTR2019-002121-30-CZActive, not recruitingPhase 1
An Open-label Study with a Nonrandomized Single-dose Phase in Subjects with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections followed by aRandomized, Multiple-dose, Active-controlled Phase in Subjects with Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age - APEKS-PEDI
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Shionogi B.V.
- Enrollment
- 85
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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