DEVELOPMENT OF PATHOGEN-TARGETED ANTIMICROBIALS
Infections
INFECTIOUS DISEASES, INFECTIONS
Pathogen-targeted antimicrobial drug development is one tool for addressing the increasing challenge caused by AMR [Pathogen-targeted development program (adapted from [In 2012, the Infectious Diseases Society of America (IDSA) issued a white paper with recommendations on study designs for clinical trials of antimicrobials for treating drug-resistant pathogens that included suggestions for conducting superiority clinical trials and the use of rapid diagnostic testing to confirm the presence of target pathogens [Working with experts, the FDA crafted recommendations and guidance to industry for developing pathogen-targeted antibiotics [The designs of clinical trials for pathogen-targeted antimicrobials face some unique challenges that are not encountered with those for traditional broad-spectrum agents. Infections due to MDR pathogens in nosocomial settings often arise in the presence of prolonged hospital stays, antibiotic use, indwelling device usage, and complicated illnesses, making them more difficult to treat. Clinical trials to evaluate effective therapies for MDR pathogens are equally difficult because of these factors, along with the challenge of identifying the targeted patient population while facing diagnostic uncertainty and delay [