Feasibility study of novel hand hygiene formulations against bacterial spore infection

新型手部卫生制剂对抗细菌芽孢感染的可行性研究

• 批准号: 10542696
• 负责人: Stephen Hsu
• 金额: $ 26.66万
• 依托单位: CAMELLIX, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10542696
• 关键词: Address; Alcohols; Animals; Bacillus; Bacillus cereus; Bacillus subtilis; Bacteria; Bacterial Spores; Beverages; Cells; Centers for Disease Control and Prevention (U.S.); Clostridium difficile; Collaborations; Consult; Data; Development; Diagnosis; Disinfectants; Drainage procedure; Effectiveness; Environment; Epigallocatechin Gallate; Feasibility Studies; Food; Food Industry; Food Poisoning; Formulation; Funding; Future; Gel; General Population; Germicide; Germination; Goals; Grant; Hand; Hand functions; Health; Healthcare; Home; Human; Hygiene; Industrial fungicide; Industry; Infection; Infection prevention; Laboratories; Laboratory Research; Legal patent; Liquid substance; Local Anti-Infective Agents; Long-Term Care; Methods; Monograph; Operative Surgical Procedures; Palmitates; Pathogenicity; Persons; Phase; Prevention strategy; Process; Publishing; Regulation; Reproduction spores; Research Personnel; Resistance; Risk; Skin; Small Business Technology Transfer Research; Soaps; Surface; Suspensions; System; Technology; Testing; Toxic effect; United States; United States National Institutes of Health; Universities; Water; Work; bactericide; base; care systems; clinical risk; commercialization; cytotoxicity; cytotoxicity test; efficacy testing; experience; experimental study; feasibility testing; health care settings; healthcare-associated infections; high risk; high risk population; human old age (65+); novel; opportunistic pathogen; pathogenic bacteria; prevent; product development; prototype; research and development; safety testing; stability testing; virucide

Project Summary: Spore-forming bacterial species, such as various Bacilli and Clostridia, undergo a sporulation process under unfavorable conditions to form dormant spores. These bacterial spores have become a threat to the food industry as they can cause food spoilage and food poisoning. In addition, an opportunistic pathogen, Clostridium difficile (C. difficile), one of the five CDC- listed urgent threats, causes Clostridium difficile infection (CDI) in the healthcare and long- term care systems. Unfortunately, there are currently no sporicidal hand hygiene products. Hand wash with soap and water is the only recommended method to prevent CDI either in healthcare settings or at home (CDC, C. difficile: Prevent the spread of C. difficile). It is known that soap and water do not inactivate bacterial spores, but rather remove them from the skin into the water drainage system. Thus, hand hygiene methods with high sporicidal activity, yet without toxicity, are in urgent need to better protect the general population from infections caused by spore-forming bacteria. Based on patented and patent-pending technologies, Camellix, LLC has developed novel alcohol-based formulations containing epigallocatechin-3- gallate-palmitate (EC16), a compound derived from green tea polyphenols, which showed potent sporicidal activity in initial tests. In the current proposal, investigators from Camellix and Seton Hall University will: determine and validate the sporicidal activity of novel alcohol-based formulations containing epigallocatechin-3-gallate-palmitate (EC16) against a wide spectrum of bacterial spores and can provide novel hand hygiene methods without toxicity (Aim 1). The selected formulations with potent sporicidal activities will be undergoing test the cytotoxicity, stability, and efficacy of finalized F1 and F2 identified in Aim 1 in comparison to currently used methods and products (Aim 2). Supported by an NIH STTR Phase II grant, Camellix is currently developing novel hand/surface disinfectants according to EPA, FDA and EU regulations and standards, and achieving expected results, which demonstrates our expertise and experience in hand hygiene product development. The proposed work will lead to first-in-class nontoxic hand hygiene prototypes against pathogenic spore-forming bacteria.

项目概要： 孢子形成细菌物种，如各种杆菌和梭菌，经历孢子形成 在不利的条件下形成休眠孢子。这些细菌孢子 成为食品工业的威胁，因为它们可能导致食物腐败和食物中毒。在 此外，机会致病菌，艰难梭菌（C.五个CDC之一， 列出的紧急威胁，导致艰难梭菌感染（CDI）在医疗保健和长期- 长期护理系统。不幸的是，目前没有杀孢子的手部卫生产品。 用肥皂和水洗手是防止CDI的唯一推荐方法， 医疗机构或在家中（CDC，C. difficile：防止C. difficile）。已知 肥皂和水并不能消灭细菌孢子，而是把它们从皮肤上清除掉。 进入排水系统因此，具有高杀孢子活性的手卫生方法， 无毒性，急需更好地保护普通人群免受感染 由孢子形成细菌引起的基于专利和正在申请专利的技术， Camellix，LLC开发了含有表没食子儿茶素-3-基的新型醇基制剂。 没食子酸棕榈酸酯（EC 16），一种来自绿色茶多酚的化合物，其显示出有效的 在初始测试中的杀孢子活性。在目前的提案中，来自Camellix和Seton的调查人员 霍尔大学将：确定和验证新型醇基杀孢子活性 含有表没食子儿茶素-3-没食子酸酯-棕榈酸酯（EC 16）的制剂对抗广谱的 细菌孢子，并可以提供新的手卫生方法无毒（目标1）。的 将对所选择的具有有效杀孢子活性的制剂进行细胞毒性测试， 目标1中确定的最终F1和F2与当前使用的F1和F2相比的稳定性和疗效 方法和产品（目标2）。在NIH STTR第二阶段资助的支持下，Camellix目前正在 根据EPA、FDA和欧盟法规开发新型手/表面消毒剂， 标准，并达到预期的结果，这表明我们的专业知识和经验， 手卫生产品开发。这项拟议的工作将导致一流的无毒手 针对致病孢子形成细菌的卫生原型。