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Review
. 2017 Jul 15;216(2):228-236.
doi: 10.1093/infdis/jix211.

White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs

Helen W Boucher  1 , Paul G Ambrose  2 , H F Chambers  3 , Richard H Ebright  4 , Amanda Jezek  5 , Barbara E Murray  6 , Jason G Newland  7 , Belinda Ostrowsky  8 , John H Rex  9   10   11 ; Infectious Diseases Society of America
Affiliations
Review

White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs

Helen W Boucher et al. J Infect Dis. .

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.

Keywords: antibiotic development; antimicrobial resistance.

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Figure 1.
Figure 1.
Pathogen-focused pathways and development [12].
See this image and copyright information in PMC

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References

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