White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs.
July 15, 2017
Helen W Boucher, Paul G Ambrose, H F Chambers, Richard H Ebright, Amanda Jezek, Barbara E Murray, Jason G Newland, Belinda Ostrowsky, and John H Rex on behalf of the Infectious Diseases Society of America
The Journal of Infectious Diseases, Volume 216, Issue 2, 15 July 2017, Pages 228–236, https://doi.org/10.1093/infdis/jix211
Despite progress in antimicrobial drug development, a critical need persists for new, feasible pathways to develop antibacterial agents to treat people infected with drug-resistant bacteria. Infections due to resistant gram-negative bacilli continue to cause unacceptable morbidity and mortality rates. Antibacterial agents have been historically studied in noninferiority clinical trials that focus on a single site of infection (eg, complicated urinary tract infections, intra-abdominal infections), yet these designs may not be optimal, and often are not feasible, for study of infections caused by drug-resistant bacteria. Over the past several years, multiple stakeholders have worked to develop consensus regarding paths forward with a goal of facilitating timely conduct of antimicrobial development. Here we advocate for a novel and pragmatic approach and, toward this end, present feasible trial designs for antibacterial agents that could enable conduct of narrow-spectrum, organism-specific clinical trials and ultimately approval of critically needed new antibacterial agents.