Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Eradication of multi-drug resistant bacteria
研究概览
简要总结
The purpose of this study was :
- to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
- to determine the effect of inhaled antibiotics on respiratory infection
详细描述
Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.
Systemic antibiotics are administered by the responsible physician
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be on mechanical ventilation greater than 3 days
- •greater than or equal to 18 years and survival greater than 14 days
- •organisms on Gram stain with increasing purulent secretions
排除标准
- •pregnancy
- •allergy to drugs administered
研究组 & 干预措施
Drug: vancomycin or gentamicin
vancomycin 120 mg every 8 hours or gentamicin 80 mg every 8 hours
干预措施: vancomycin or gentamicin (Drug)
Drug: Placebo
normal saline 2 mL nebulized Q 8 hours placebo for gentamicin or vancomycin
干预措施: Placebo (Drug)
结局指标
主要结局
Eradication of multi-drug resistant bacteria
时间窗: Randomization and at end of treatment
Tracheal aspirates are taken at randomization. Randomization to drug is determined by the Gram stain(organisms are Gram-positive, Gram-negative or both). End of treatment culture, susceptibility and Gram stain of tracheal aspirate is taken after 14 days of treatment or at time of extubation, (which ever comes first). Eradication is defined as absence of growth in culture and absence of organisms on Gram stain.
次要结局
- Clinical Pulmonary Infection Score (CPIS)(Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.)