EUCTR2015-002779-64-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 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Including Peri-Operative Prophylactic Use of Antibiotics
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
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
- •- 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 3 months and 24 months, 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 inotropic or vasodilatory support to manage blood pressure) in the
- •24 hour window prior to first dose, and no history or evidence of renal or hepatic
- •- Suspected or diagnosed bacterial infection for which the subject was receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively
- •- A calculated creatinine clearance rate (CLcr) = 80 ml/min/1.73m2 as determined by the Schwartz equation at Baseline
- •- Creatine kinase levels less than 2 × upper limit of normal (ULN) at Baseline
- •- Presence of two patent i.v. lines (or comparable means of venous or arterial access) prior to dosing on Study Day 1. A single i.v. line (or comparable means of venous access) was acceptable for both drug administration and sample collection if reasonable effort to gain a second line was unsuccessful. The line had to be flushed prior to obtaining PK samples. Pharmacokinetic sample could have been obtained from a peri-operatively placed arterial line. Arterial PK samples should have been indicated on the case report form (CRF).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 23
- •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
- •- 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, renal, hepatic, autoimmune disease or primary
- •immune deficiency
- •- Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator
- •- Administration of rifampin within 7 days of study drug administration
- •- Subjects in whom collection of the required blood volume would have put them at risk of hemodynamic disturbance (at the discretion of Investigator)
- •- Planned administration of intramuscular injection within 12 hours following study drug administration unless approved by the Medical Monitor
- •- Guillain-Barré or spinal cord injury
- •- History of or current rhabdomyolysis
研究者
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