Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- Side effects of nasal photodisinfection
研究概览
简要总结
This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.
详细描述
The purpose of the proposed study is to gather data regarding the safety and efficacy of nasal photodisinfection treatment in eliminating colonization of the anterior nares with S. aureus. The anterior nares are often considered the primary reservoir of S. aureus and other pathogens on the body, therefore, this product could play an important role in helping to eliminate this pathogen reservoir in patients. Since photodisinfection is a non-antibiotic approach that does not generate antibiotic resistance, this could be a beneficial approach to achieving nasal disinfection. Additionally, photodisinfection has an extremely broad spectrum of activity and is effective against bacterial, viral, and fungal pathogens including emerging pathogens such as C. auris.
This is a Phase 2 study. Nasal cultures will be performed on all patients admitted for surgery at Memorial Health University Medical Center over a 1-month period. This will determine the prevalence rate of S. aureus and other pathogens in community patients who are being admitted for surgery. The results of this culture will not be known to the research staff until several days later. Clinical trial subjects will universally receive a nasal disinfection treatment followed by a post-treatment culture. This will demonstrate the efficacy of nasal disinfection against Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
As an infection prevention study the intervention of nasal photodisinfection will be applied to all willing participants within the time frame. Pre and post intervention nasal cultures will be performed. Clinicians will not be aware of these results during the patients hospital course.
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
- •Provision of signed and dated informed consent form within 30 days of surgery.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female ≥ 18 years of age.
- •Patient being admitted for a surgical procedure.
- •Ability to tolerate a 4-minute non-painful nasal light illumination.
排除标准
- •Male or female <18 years of age.
- •Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants.
- •Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
- •Nasal obstructions precluding placement of light illuminator.
结局指标
主要结局
Side effects of nasal photodisinfection
时间窗: 30 days
Subjects will be evaluated for any treatment related side effects including rhinorrhea, mucosal irritation, laryngeal irritation, sneezing or any reported adverse event.
Microbiological efficacy
时间窗: Within 1 hour of start of surgery
All pre-surgical subjects will be screened by plate culture for Staphylococcus aureus nasal carriage. All subjects will receive the nasal decolonization treatment and then be screened again for Staphylococcus aureus carriage.
次要结局
- Incidence of surgical site infections(30 days)