White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs. (5th May 2017)

• Record Type: Journal Article
• Authors: Boucher, Helen W; Ambrose, Paul G; Chambers, H F; Ebright, Richard H; Jezek, Amanda; Murray, Barbara E; Newland, Jason G; Ostrowsky, Belinda; Rex, John H
• Is Part Of: Journal of infectious diseases. Volume 216:Number 2(2017:Jul. 15)
• Page Start: 228
• Page End: 236
• Publication Date: 2017-05-05
• Subjects: antimicrobial resistance -- antibiotic development; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jix211
• Languages: English
• ISSNs: 0022-1899

Abstract

Summary: To meet the need for new pathways to develop antibacterial agents to treat drug-resistant infections, we present feasible trial designs that could enable conduct of narrow-spectrum clinical trials and ultimately approval of critically needed new antibacterial agents. Abstract: 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.