Novel hand hygiene product to remove Clostridioides difficile spores

7.项目摘要/摘要 艰难梭菌现在在美国引起的医院感染和死亡比任何其他病原体都多，而且 这是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， 年，估计有462,100例与医疗保健和社区相关的艰难梭菌感染病例。 美国，以及20,500例住院死亡。在一项随机试验中，肥皂和水洗涤30秒的时间减少了 但并未消除CDI患者或无症状携带艰难梭菌患者的手部污染，而 酒精手部卫生没有影响。医护人员的手经常被C。 艰难的孢子，但用肥皂和水洗手只有适度的效果，而酒精洗手 消毒剂基本上对孢子没有效果。因此，有一个重要的未得到满足的发展需要。 有效的战略，以减轻手上的孢子负担。考虑到未被认识到的担忧 无症状携带者对传播的贡献很大，迫切需要全面 适用于直接护理CDI患者的人，以及更广泛地适用于所有人的方法 卫生保健。 我们开发了一种实用和高度创新的方法来满足这种需求，通过开发 一种能有效减少皮肤上艰难梭菌孢子的杀孢子手洗液。我们的洗手水 配方是基于使用一种由微纤维纤维素制成的新型微结构流体(MSF) 它通过物理和机械手段显著增强了艰难梭菌孢子从皮肤上的去除。 与传统的肥皂和水相比。洗涤过程中皮肤表面产生的剪应力 与传统肥皂和水相比，MSF高出10到100倍。 重要的是，我们最近发现，当微结构流体与新型包裹体一起制成时 和皮肤安全的杀孢子组分，在中性pH下，我们能够实现艰难梭菌孢子的∼3.5对数减少。 经综合检测，猪皮在30秒内脱脂。这一发现构成了一个重要的 对传统肥皂和水的改进，原则上应该导致高度肯定的预防 传播艰难梭菌感染。这一新发现意义重大，因为目前以酒精为基础的洗手液 对艰难梭菌的孢子无效。本课题的主要工作是：1)对无国界医生的手进行优化和定型 基于已建立皮肤模型的测试的洗涤配方，目标是实现&gt；3减少原木 来自皮肤的C.diff孢子和重要的HAI感染；2)制造无国界医生组织洗手产品 GMP，进行兼容性/稳定性研究并制定质量控制要求；以及3)测试 无国界医生手洗皮肤的安全性和耐受性符合FDA的要求。

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.