Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cure rate
研究概览
简要总结
The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.
详细描述
After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05.
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
- •Age >/= 18 years
- •On mechanical ventilator more than 7 days
- •VAP diagnosis inclusion criteria:
- •new/progressive infiltration of chest radiography
- •2/3 of the following: 1) fever 2) purulent sputum 3) Wbc > 12,000 cell/mm3 or < 4,000 cell/mm3
- •Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week
排除标准
- •History of amikacin allergy
- •GFR < 30 mL/min except dialytic patients
- •Immunocompromised host: HIV CD4 < 200 cells/mm3, leukemia, lymphoma, received chemotherapy within 3 weeks, Absolute neutrophil count < 500/mm3
- •Severe ARDS (P/F ratio < 100)
- •Endobronchial obstruction:endobronchial mass, endobronchial stenosis
- •Atelectasis
- •Severe bronchospasm
- •Lung abscess
- •Complicated parapneumonic effusion/ Empyema
- •Chest trauma
- •Uncontrolled extrapulmonary infection(s)
- •Received intravenous antibiotic(s) more than 48 hours
- •Pregnancy/ Lactation
研究组 & 干预措施
placebo
nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days.
干预措施: Placebo (Drug)
Nebulized amikacin
Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days
干预措施: Amikacin (Drug)
结局指标
主要结局
cure rate
时间窗: 10 days after end of the intervention
Cure rate = improvement/ no new infiltration of chest radiography plus 2/3 of the following: 1) No fever within 48 hours after end of the intervention 2) The reduction of secretion 3) The reduction of white blood cell
次要结局
- duration of mechanical ventilation(at 28 days after end of the intervention)
- duration of ICU stay(at 28 days after end of the intervention)
- The reduction of pathogens(10 days after end of the intervention)
- mortality rate(at 28 days after end of the intervention)
- duration of hospitalization(at 28 days after end of the intervention)
- Safety of intervention drug(at 28 days after end of the intervention)
研究者
Pitchayapa Ruchiwit
Principal investigator
Thammasat University