Nebulized Polymyxin E and Amikacin for the prevention of ventilator-associated pneumonia-A double-blind randomized clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- To compare the first episode of VAP in between the two groups from randomization
研究概览
简要总结
The nebulized polymyxin E vs amikacin to prevent ventilator-associated
pneumonia is an investigator-initiated, double-blind, parallel-arm, randomized, clinical
study.
After approval from institutional ethical committee, written and informed
consent will be taken from the patient’s attendant.
Total 276 patients will be included in this study and they will be divided into two
groups of 138 each by using computer generated number.
GROUP P(n=138): Polymyxin E 5.5 mg/kg/day in the nebulized form
GROUP A(n=138): Amikacin 20 mg/kg/day in the nebulized form
In both the groups, the drugs will be given twice daily for 3 consecutive days
with the help of vibrating mesh nebulizer (aerogen). Preparation of the study drugs will
be done by the nursing staff, not involved in the study.
Ventilator settings, sedation and muscle relaxants will be at the discretion of the
attending physician. However, general guidance on nebulization will be provided.
The primary outcome will be the occurrence of ventilator-associated
pneumonia. All the relevant data will be collected after start of study till 28 days or
mortality of the patient whichever occurs earlier. Patient will be monitored carefully
during the study period.
Clinical pulmonary infection score (CPIS)>6 and/or positive endotracheal
aspirate culture which will be sent every third day will be considered as patients having
ventilator-associated pneumonia .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are expected to be on mechanical ventilation for at least 72 hours.
排除标准
- •Patients who are already on mechanical ventilation for more than 96 hours.
- •2.Patients who are already diagnosed with or a suspected case of pneumonia 3.Patient with chronic kidney disease
- •Positive pregnancy test at the time of inclusion
- •Patient scheduled for extubation within the next 24 hours
- •Patient known to be allergic to aminoglycosides or polypeptide antibiotics at the time of inclusion.
- •Patients who are already on systemic aminoglycoside or polypeptides antibiotics 8.Patients who are tracheostomized.
结局指标
主要结局
To compare the first episode of VAP in between the two groups from randomization
时间窗: 28 Days
to Day 28 on the basis of Clinical Pulmonary Infection Score(CPIS),
时间窗: 28 Days
次要结局
- To compare the median length of stay in days (ICU and Hospital).(28 Days)
- To compare the median number of days on mechanical ventilation from(randomization to Day 28.)
- To compare the median number of days from randomization to first successful(spontaneous breathing trial.)
- Adverse reaction in between the two groups due to nebulization.(28 Days)
研究者
Harish Kumar
Uttarpradesh university of medical sciences