EUCTR2019-002121-30-LT进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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