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Clinical Trials/EUCTR2019-002121-30-LT
EUCTR2019-002121-30-LTActive, not recruitingPhase 1

An Open-label Study with a Nonrandomized Single-dose Phase in Subjectswith Suspected or Confirmed Aerobic Gram-negative Bacterial Infectionsfollowed by a Randomized, Multiple-dose, Active-controlled Phase inSubjects with Suspected or Confirmed Complicated Urinary Tract Infection(cUTI), Hospital-acquired Pneumonia (HAP) or Ventilator-associatedPneumonia (VAP) to Assess the Safety, Tolerability, and Pharmacokineticsof Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years ofAge - APEKS-PEDI

Shionogi B.V.0 sites85 target enrollmentStarted: November 27, 2019Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
85
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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(s) (LAR)[s])
  • •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, and sepsis or BSI) that requires hospitalization for treatment with IV antibiotics.
  • •Multiple-dose phase: Subject has a suspected or confirmed cUTI (with a positive urine dipstick test for pyuria and, when possible, microscopy
  • •demonstrating = 105 colony forming units (CFU)/mL in a midstream urine specimen or = 5 x 104 CFU/mL in a clean catheter catch urine
  • •specimen) or HAP, or VAP that requires hospitalization for treatment with IV antibiotics.
  • •5. 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.
  • •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

  • •1. 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 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 m2
  • •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 m2 at
  • •Screening. See Protocol Section 7.5.3.1.2 for eGFR calculations and
  • •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.

Investigators

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