Novel hand hygiene product to remove Clostridioides difficile spores

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.