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; 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.

项目摘要： 形成孢子的细菌物种，例如各种细菌和梭状芽胞杆菌，发生孢子形成 在不利条件下形成休眠孢子的过程。这些细菌孢子有 成为对食品行业的威胁，因为它们可能导致食品变质和食物中毒。在 另外，机会性病原体，艰难梭菌（艰难梭菌），这是五个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 术语护理系统。不幸的是，目前没有孢子性手动卫生产品。 用肥皂和水洗手是防止CDI在 医疗保健环境或在家（CDC，艰难梭菌：防止艰难梭菌的传播）。我们都知道 那种肥皂和水不会使细菌孢子失活，而是将它们从皮肤上移出 进入排水系统。因此，具有高孢子活性的手卫生方法 没有毒性，迫切需要更好地保护普通人群免受感染 由形成孢子的细菌引起。基于获得专利和申请专利的技术， Camellix，LLC开发了含有epigallocatechin-3-的新型酒精制剂 五核酸酯（EC16），一种衍生自绿茶多酚的化合物，该化合物表现出有效性 初始测试中的孢子活性。在当前的建议中，来自Camellix和Seton的调查员 霍尔大学将：确定并验证新型酒精的孢子活性 含有跨多种光谱的配方（EC16） 细菌孢子，可以提供新的手动卫生方法而无需毒性（AIM 1）。这 具有有效孢子活性的选定配方将在测试细胞毒性， 与当前使用 方法和产品（AIM 2）。在NIH STTR II阶段赠款的支持下，Camellix目前是 根据EPA，FDA和欧盟法规，开发新型的手/表面消毒剂以及 标准以及实现预期结果，这证明了我们的专业知识和经验 手卫生产品开发。拟议的工作将导致第一类无毒的手 针对病原孢子形成细菌的卫生原型。