A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
研究概览
简要总结
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria: Key Inclusion Criteria:
- •Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
- •Hospitalized infants from birth to < 3 months (< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
- •Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
- •For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection
排除标准
- •Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
- •Life expectancy of < 72 hours after enrollment
- •Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
- •Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1
- •Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
- •Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
- •Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
- •Receiving renal replacement therapy
- •Received any other investigational medicinal product within 30 days of study drug administration
- •Receiving treatment with a vasopressor at Screening
- •Has a confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection
- •Anticipated need for antibacterial therapy longer than 14 days (example , osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram-positive organisms or multidrug resistant Gram-negative organisms
- •Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Single-Dose Cefiderocol
Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics
干预措施: Cefiderocol (Drug)
Single-Dose Cefiderocol
Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics
干预措施: Standard of Care (Drug)
Multiple-Dose Cefiderocol
Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics
干预措施: Standard of Care (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
时间窗: Up to 8 hours postdose
Cmax After a Minimum of 4 Doses of Cefiderocol
时间窗: Up to 8 hours postdose
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
时间窗: Up to 8 hours postdose
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
时间窗: Up to 3 hours
Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
时间窗: Up to 8 hours postdose
Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
时间窗: Up to 8 hours postdose
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 28 days)