Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose two times daily (BID) up to 100 days after transplant.
ARM II: Patients receive standard of care.
After completion of study, patients are followed up every week for 6 weeks and then every alternate week until day 100.
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
- None
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
- •Undergoing allogeneic hematopoietic transplant for malignant or non-malignant disease
- •English speaking
- •Capable of providing informed consent
- •Planned to receive follow-up at the transplant site for the first 100 days post transplantation
- •Subjects who the investigator believes can and will comply with the study protocol
排除标准
- •Documented respiratory viral infection in the two weeks prior to enrollment
- •Current or planned use of any prophylactic antiviral therapy, antibody treatments, or other agents targeting the prevention of respiratory viruses (i.e. oseltamivir, ribavirin, amantadine)
- •Known allergy to study drug components (jojoba, orange oil, coconut oil, lauric acid, benzalkonium chloride, vitamin E)
- •Receiving oxygen supplementation at time of enrollment
- •Active mucositis at time of enrollment
- •Ongoing irritation or active infection of the squamous epithelial cell skin involving the nose or nasal vestibule
- •Daily use of nasal decontamination products or other nasal medications (e.g. nasal steroids)
- •Unable to complete study procedures (e.g. nasal swab self-testing)
研究组 & 干预措施
Arm II (standard of care)
Patients receive standard of care.
干预措施: Best Practice (Other)
Arm I (Nozin)
Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose BID up to 100 days after transplant.
干预措施: Nozin (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 100 days post-transplant
AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events will be continually monitored by the study team and descriptively compared between study arms.
Tolerability of Nozin
时间窗: Up to 100 days post-transplant
Will measure and describe reasons for dropout, defined as failure to complete the study to day 100 for any reason. Among participants in the study product arm, reasons for dropout will be classified as either directly related to the product or due to other reasons. Will estimate the proportion of participants who exit the study for reasons directly related to the study product with a precision of +/- 20% (95% confidence interval) to inform tolerability of study product for future studies. Will compare dropout for any reason between treatment arms using Fisher's exact test.
次要结局
- Number of respiratory viral panel tests(Up to 100 days post-transplant)
- Incidence of community acquired respiratory viruses (CARV)(Up to 100 days post-transplant)
- Frequency of respiratory viral symptoms(Up to 100 days post-transplant)