NCT00136292已完成1 期
An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2005年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Pharmacokinetic
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-17 years old
- •Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
- •Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
- •Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
- •Creatine phosphokinase (CPK) levels within normal limits
排除标准
- •Known allergy to daptomycin
- •History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
- •Pneumonia as sole gram-positive infection
- •Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
- •Clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]), as determined by Investigator
- •Body mass index (BMI) that is outside of the 5th to 95th percentile for age
- •History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
- •Expected intramuscular (IM) injection within 3 days following dosing
- •Expected surgical procedure(s) within 3 days following dosing
- •Unexplained muscular weakness
- •Rhabdomyolysis, myositis or septic shock
结局指标
主要结局
Pharmacokinetic
次要结局
- Tolerability
研究者
研究点 (6)
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