EUCTR2014-003243-34-ES进行中（未招募）1 期
Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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. Informed consent in writing from parent(s) or other legally-acceptable representative(s)
- •2. Male or female, gestational age >-34 weeks, and chronological age 7 to <60 days at the time of screening
- •3. Diagnosis of sepsis within 36 hours before enrolment, defined as the presence of at least 2 clinical criteria and at least 2 laboratory criteria in the presence of or as a result of suspected or proven bacterial infection that requires IV antibiotic therapy.
- •4. Patients must meet at least two of the following clinical criteria:
- •(i) Hypothermia (<36°C) OR fever (>38.5°C)
- •(ii) Bradycardia OR tachycardia OR rhythm instability
- •(iii) Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR
- •impaired peripheral perfusion
- •(iv) Petechial rash OR sclerema neonatorum
- •(v) New onset or worsening of apnoea episodes OR tachypnoea episodes OR
- •increased oxygen requirements OR requirement for ventilation support
- •(vi) Feeding intolerance OR poor sucking OR abdominal distension
- •(vii) Irritability
- •(viii) Lethargy
- •(ix) Hypotonia.
- •5. Patients must meet at least two of the following laboratory criteria:
- •(i) White blood cell count <-4,000 × 109/L OR >-20,000 × 109/L
- •(ii) Immature to total neutrophil ratio >0.2
- •(iii) Platelet count <-100,000 × 109/L
- •(iv) C-reactive protein (CRP) >15 mg/L OR procalcitonin >-2 ng/mL
- •(v) Hyperglycaemia OR Hypoglycaemia
- •(vi) Metabolic acidosis.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •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. Documented history of any hypersensitivity or allergic reaction to any beta-lactam antibiotic or aminoglycoside
- •2. At study entry, has confirmed infection with a pathogen known to be resistant to the combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection
- •3. Refractory septic shock within 24 hours before enrolment that does not resolve after 60 minutes of vasopressor therapy
- •4. Moderate or severe renal impairment defined as serum creatinine >-2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis
- •5. Evidence of progressively fatal underlying disease, or life expectancy of <-60 days
- •6. Documented history of seizure
- •7. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or a child from an HIV positive mother
- •8. Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC)
- •9. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the investigator, make the patient unsuitable for the study, place a patient at risk, or compromise the quality of data
- •10. Patient's parent(s) or legally-acceptable representative(s) involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Concurrent participation in another clinical study with an investigational product (IP), previous enrolment/participation in this study, or participation in another study of ceftaroline fosamil within 14 days before the intended start of the first dose of study therapy.
研究者
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