ACTRN12612000273886已完成1 期
A randomised, double blind, placebo controlled, dose escalation study of aerosolized Amikacin and Fosfomycin delivered via the PARI investigational eFlow inline nebulizer system in mechanically ventilated patients.
Cardeas Pharma0 个研究点目标入组 9 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Clinical diagnosis of VAP or VAT and expected to be on mechanical ventilation for at least 3 days
- •Gram positive or gram negative stain of the tracheal aspirate
- •Able to produce 1ml of tracheal aspirate for PK analyses
排除标准
- •1.Severely compromised or suppressed immune system prior to hospital admission
- •2.Fraction of Inspired Oxygen (FIO2) > 0.8 at enrolment
- •3.Relative hypoxemia (O2 saturation of less than 93% on an FIO2 =0.8) at enrolment
- •4.PEEP > 15cm H2O at enrolment
- •5.Creatinine > 0.18 mmol/L
- •6.Positive pregnancy screening test or breast feeding (for female participants only)
- •7.Burns to greater than 40% of the body
- •8.Current treatment with systemic amikacin or fosfomycin within 48 hours of dosing
- •9.A history of previous allergy or sensitivity to amikacin or fosfomycin
- •10.Participation in a clinical study with administration of an investigational drug product within three months of Investigational Product administration.
- •11.Blood hemoglobin < 70 g/L at enrolment.
- •12.Any other condition which in the view of the Investigator is likely to interfere with the study or put the patient at risk.
研究者
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