EUCTR2011-002198-44-Outside-EU/EEA进行中（未招募）不适用
Pharmacokinetics of a Single Dose of Ceftarolinefosamil in Children Ages Birth to Younger Than 12Years With Suspected or Confirmed Infection - Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children
Cerexa, Inc. (subsidary of Forest Laboratories)0 个研究点目标入组 56 人开始时间: 2011年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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. Written informed consent from parent(s) (or other legally acceptable
- •representative[s]) and verbal informed assent from subject (if age
- •appropriate; according to local requirements)
- •2. Male or female children with ages from birth to younger than 12
- •3. Hospitalized and receiving antibiotic therapy for treatment of a
- •suspected or confirmed systemic
- •4. Negative urine pregnancy test (if female and has reached menarche)
- •5. Sufficient intravascular access (peripheral or central) to receive
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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. History of any hypersensitivity or allergic reaction to any ß-lactam
- •antimicrobial (eg, cephalosporins, penicillins)
- •2. Past or current history of epilepsy or seizure disorder (excluding
- •childhood febrile seizures)
- •3. Moderate or severe renal impairment such that: ? Cohorts 1, and 2 ,
- •and 3: Creatinine clearance (CrCl) < 50 mL/min
- •calculated using the modified Schwartz equation (Schwartz et al, 1987):
- •CrCl (mL/min/1.73m2) = [length (cm) x k] / Serum creatinine
- •- k = 0.45 for infants 1 to 52 weeks old
- •- k = 0.55 for children 1 to 12 years old
- •? Cohorts 4 and 5:
- •- Urine output with value of < 1 mL/min/kg (measured in diapered
- •children as diaper weight
- •change where 1 g = 1 mL of urine) and
- •- Serum creatinine value of > 1.3 mg/dL
- •Note: For Cohort 3, if calculated CrCl is between 50-60
- •mL/min/1.73m2, and the child is age
- •24 months or under, please ensure urine output and serum creatinine
- •values are within normal or mild renal impairment criteria as for
- •Cohorts 4 and 5 (ie, urine output = 1mL/kg/min [measured in diapered
- •children as diaper weight change where 1 g = 1 mL of urine] and serum
- •creatinine = 1.3 mg/dL)
- •4. Aspartate aminotransferase, alanine aminotransferase, or total
- •bilirubin level > 3 times upper limit of
- •normal (neonates with elevated total bilirubin may participate if
- •conjugated bilirubin is normal)
- •5. Any condition (eg, septic shock, acute hemodynamic instability
- •including those requiring pressor
- •support) that would make the subject, in the opinion of the
- •Investigator, unsuitable for the study (eg,
- •would place a subject at risk or compromise the quality of the data)
- •6. Receipt of a blood transfusion during the 24-hour period before
- •7. Use of probenecid within 3 days prior to dosing
- •8. If female, currently pregnant or nursing
- •9. Previous participation in this study or in any study involving
- •administration of an investigational agent
- •within 30 days prior to enrollment into this study where the subject
- •was randomized and received an
- •active investigational product (not placebo)
- •10. Unwilling or unable to adhere to study procedures or restrictions
研究者
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