The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of ventilator-associated pneumonia (VAP)
研究概览
简要总结
Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •invasive mechanical ventilation beyond 48 hours
排除标准
- •hospital - acquired pneumonia
- •community - acquired pneumoniae
- •BMI > 35 kg/cm2
- •pregnancy
- •tracheostomy
- •reintubation
研究组 & 干预措施
Control group
干预措施: Control (Drug)
Antiseptic (Octenisept) group
干预措施: Antiseptic Solution (Drug)
Bacteriophage (Sextaphag) group
干预措施: Bacteriophage (Drug)
结局指标
主要结局
Incidence of ventilator-associated pneumonia (VAP)
时间窗: Change from Baseline CPIS at 14 days
CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed
Changing of oral and lung microbiomes
时间窗: Change from Baseline Microbiology researching at 14 days
Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit
次要结局
- Concentration of C - reactive protein (CRP)(Change from Baseline CRP at 14 days)
- Organ dysfunction(Change from Baseline Sequential Organ Function Assessment at 14 days)
- Concentration of Procalcitonin (PCT)(Change from Baseline PCT at 14 days)
- Rate of Mortality(Change from Baseline PCT at 28 days)
研究者
Vsevolod V. Kuzkov
Principal investigator
Northern State Medical University