NCT00841074已完成1 期
Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pneumonia
研究概览
简要总结
The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be at least 65 years old.
- •Be dependent in 2 or more Activities of Daily Living as noted on the nursing home resident's Minimum Data Set - One must be ADL J- Personal Hygiene.
- •Have natural teeth and/or wear complete or partial dentures.
- •Expected to be a resident in a nursing home for two years.
排除标准
- •Existing pneumonia.
- •History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies.
- •Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.
研究组 & 干预措施
1
Experimental
Peridex mouthwash
干预措施: chlorhexidine (Drug)
2
Placebo Comparator
Placebo mouthwash
干预措施: Placebo mouthwash (Drug)
结局指标
主要结局
Pneumonia
时间窗: 12 months
次要结局
- Plaque and Gingival Indices(12 months)
- Respiratory pathogens(12 months)
研究者
Catherine J Binkley
PI
University of Louisville
研究点 (1)
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