Description of Collaborative Activity: |
This project addresses key regulatory considerations relevant to using bacteriophages for decolonization of the drug-resistant nosocomial pathogens, vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). These include characterizing pathogen resistance to phage, defining phage mixtures ("cocktails") to circumvent resistance, optimizing mouse models to evaluate pathogen decolonization, and identifying endpoints that support claims for clinical benefit (e.g., reduced risk of disease transmission). |