EUCTR2015-002781-23-Outside-EU/EEA进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •Male or female subjects between the ages of 2 and 6 years old, inclusive, with suspected or diagnosed Gram-positive infection for which the subject was receiving standard antibiotic therapy were specific candidates for the study. Subjects were required to be 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, with calculated creatinine clearance rate (CLcr) ?80 mL/min/1.73 m2 as determined by the Schwartz equation, CPK levels <2X upper limit of normal (ULN), and presence of 2 patent i.v. lines (or comparable means of venous access) prior to dosing on Study Day 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •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
- •Subjects were to be excluded from the study if they met any of the following criteria:
- •1.Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- •2.Known allergy/hypersensitivity to daptomycin
- •3.History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma was acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
- •4.Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
- •5.Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator;
- •6.Administration of rifampin within 7 days of study drug administration;
- •7.Body mass index (BMI) that was outside of the 5th to 95th percentile;
- •8.Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
- •9.History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
- •10.Administration of intramuscular (IM) injection between baseline and study drug administration or expected IM injection within 24 hours following dosing;
- •11.Expected surgical procedure(s) within 24 hours prior to and following dosing;
- •12.Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
- •13.History of or current rhabdomyolysis.
研究者
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