Novel hand hygiene product to remove Clostridioides difficile spores

新型手部卫生产品可去除艰难梭菌孢子

• 批准号: 10603462
• 负责人: MOHAMED E LABIB
• 金额: $ 99.4万
• 依托单位: NOVAFLUX, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-09 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603462
• 关键词: Adopted; Adult; Alcohol consumption; Alcohols; Bathing; Caring; Cellulose; Cessation of life; Clostridium difficile; Communities; Developed Countries; Development; Diarrhea; Disease Outbreaks; Epidemic; Excision; Family suidae; Formulation; Goals; Hand; Handwashing; Health Care Costs; Health Personnel; Healthcare; Hospitals; Human Resources; Hygiene; Incidence; Industry; Infection; Infectious Agent; Infectious Skin Diseases; Ingestion; Liquid substance; Marketing; Mechanics; Medical center; Methods; Modeling; Norovirus; Nosocomial Infections; Organism; Patients; Performance; Persons; Phase; Physicians; Prevention; Quality Control; Reproduction spores; Resistance; Safety; Scientist; Skin; Soaps; Structure; Surface; Testing; United States; Virion; Water; experience; health care settings; improved; innovation; manufacture; novel; pathogen; prevent; randomized trial; safety testing; shear stress; skills; transmission process

7. Project Summary/Abstract C. difficile now causes more hospital-onset infections and deaths in the US than any other pathogen and is the most important cause of healthcare-associated diarrhea among adults in industrialized countries. In 2017, there were an estimated 462,100 combined healthcare- and community-associated C. difficile infection cases in the US, and 20,500 in-hospital deaths. In a randomized trial, soap and water washing for 30 seconds reduced but did not eliminate hand contamination in patients with CDI or asymptomatic carriage of C. difficile, whereas alcohol hand hygiene had no effect. The hands of healthcare workers frequently become contaminated with C. difficile spores, but hand washing with soap and water has only modest efficacy, and alcohol-based hand sanitizers have essentially no efficacy against spores. Thus, there is an important unmet need for development of effective strategies to reduce the burden of spores on hands. Given the concern that unrecognized asymptomatic carriers contribute significantly to transmission, there is an urgent need for comprehensive approaches applicable to persons who directly care for CDI patients, and also more generally for all hand hygiene. We have developed a practical and highly innovative approach to meet this need through the development of a sporicidal hand wash that is effective in significantly reducing C. difficile spores on skin. Our hand wash formulation is based on the use of a new class of microstructured fluid (MSF) made with microfibrillated cellulose which significantly enhances the removal of C. difficile spores from skin by physical and mechanical means compared to traditional soap and water. The shear stresses generated at the skin surface during washing with MSF are 10 to 100 times higher when compared to what can be obtained with traditional soap and water. Importantly, we have recently discovered that when the microstructured fluid is made with the inclusion of novel and skin-safe sporicidal ingredients at neutral pH, we are able to achieve ∼3.5 log reduction of C. difficile spores from porcine skin in 30 seconds according to comprehensive testing. This discovery constitutes a significant improvement over conventional soap and water, and in principal, should result in high assurance prevention of transmitting C. difficile infection. This new discovery is significant since current alcohol-based hand sanitizers are ineffective against C. difficile spores. This project is focused on: 1) optimizing and finalizing the MSF hand washing formulation based on testing with an established skin model with the goal of achieving >3 log reduction of C. diff spores and important HAI infections from skin; 2) manufacturing the MSF hand wash product under GMP, performing compatibility/stability studies and developing quality control requirements; and 3) testing the safety and tolerability of the MSF hand wash on skin as required by FDA.

7。项目摘要/摘要 现在，艰难梭菌在美国引起的医院发作和死亡比其他任何病原体都多，并且 工业化国家成年人中与医疗保健相关的腹泻的最重要原因。 2017年， 估计有462,100个合并的医疗保健和社区相关的艰难梭菌感染病例 美国和20,500例院内死亡。在随机试验中，肥皂和水洗30秒 但没有消除CDI或艰难梭菌的非对称载体患者的手污染，而 酒精手卫生无效。医护人员的手经常被C污染。 艰难的孢子，但用肥皂和水洗手只有适度的轻松，酒精基的手 消毒剂基本上没有针对孢子的效率。那是一个重要的发展需求 有效减少孢子燃烧的有效策略。考虑到无法识别的关注 无症状的载体对传输产生了重大贡献，迫切需要综合 适用于直接关心CDI患者的人，也更普遍地用于全方位 卫生。 我们已经开发了一种实用且高度创新的方法来通过开发来满足这一需求 有效减少皮肤上的艰难梭菌孢子有效的孢子洗手液。我们的洗手 形成是基于使用微纤维纤维素制成的新的微结构流体（MSF）的使用 通过物理和机械手段，可以显着增强艰难梭菌从皮肤上的去除 与传统的肥皂和水相比。洗涤过程中在皮肤表面产生的剪切应力 与传统的肥皂和水可以获得的相比，无国界医生高出10至100倍。 重要的是，我们最近发现，当微结构流体被包含在内时 和中性pH下的皮肤安全孢子成分，我们能够实现约3.5的艰难梭菌孢子的降低 根据综合测试在30秒内从猪皮中进行。这一发现构成了重要的 对常规肥皂和水的改善以及总的来说，应导致高保证预防 传播艰难梭菌感染。这一新发现很重要，因为当前的基于酒精的手洗手液 对艰难梭菌孢子无效。该项目的重点是：1）优化和最终确定MSF手 用已建立的皮肤模型的测试洗涤公式，其目的是减少> 3日志 C. diff孢子和皮肤的重要HAI感染； 2）在下面制造MSF洗手产品 GMP，进行兼容/稳定性研究并制定质量控制要求； 3）测试 MSF按照FDA要求在皮肤上洗手的安全性和耐受性。