NCT00679835已完成1 期
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six 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)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年6月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmocokinetics of daptomycin
研究概览
简要总结
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
- •Male or female between the ages of 2 and 6 years old, inclusive;
- •Able to comply with the protocol for the duration of the study;
- •Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
- •Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
- •A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;
- •Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.
- •Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.
排除标准
- •Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- •Known allergy/ hypersensitivity to daptomycin;
- •History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
- •Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
- •Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;
- •Administration of rifampin within 7 days of study drug administration;
- •Body mass index (BMI) that is outside of the 5th to 95th percentile;
- •Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
- •History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
- •Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;
- •Expected surgical procedure(s) within 24 hours prior to and following dosing;
- •Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;
- •History of or current rhabdomyolysis.
研究组 & 干预措施
Group 1
Experimental
8 mg/kg over a one hour infusion
干预措施: daptomycin (Drug)
Group 2
Experimental
10mg/kg over a one or two hour infusion
干预措施: daptomycin (Drug)
结局指标
主要结局
Pharmocokinetics of daptomycin
时间窗: From pre-dose to 24 hours post-dose
次要结局
- Safety of daptomycin(Up to 9 days after dosing)
研究者
研究点 (1)
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