CTIS2023-503757-35-00进行中（未招募）1 期
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 - 1904R2136
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Written informed consent has been provided by parent(s) or legally authorized representative(s) (LAR) 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 kg., Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections, including but not limited to, cUTI, cIAI, HABP/VABP, 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 Gramnegative infection
排除标准
- •Documented history of any moderate or severe 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), Receiving treatment with a vasopressor at Screening, 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 (eg, 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 patients with suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, patients who have evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, and patients with a LP with organisms on Gram stain or culture-positive CSF, Life expectancy of < 72 hours after enrollment, Urine output < 1.0 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 in the Protocol 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 mg/dL (133 µmol/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 patient or the quality of the study data, Receiving renal replacement therapy, Received any other investigational medicinal product within 30 days of study drug administration
研究者
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