@article{34c1709c92da41e0bc1bddc1418392ed,
title = "White paper: Developing antimicrobial drugs for resistant pathogens, narrow-spectrum indications, and unmet needs",
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",
author = "Boucher, {Helen W.} and Ambrose, {Paul G.} and Chambers, {H. F.} and Ebright, {Richard H.} and Amanda Jezek and Murray, {Barbara E.} and Newland, {Jason G.} and Belinda Ostrowsky and Rex, {John H.}",
note = "Funding Information: Potential conflicts of interest. H. W. B. is a consultant to Actelion (Data Safety Monitoring Committee) and the National Institute of Allergy and Infectious Disease (Adjudication Committee). P. G. A. is president of the Institute for Clinical Pharmacodynamics, a special government employee for the Department of Health and Human Services, and scientific advisor and consultant for Achaogen, Actelion, AiCuris, Arsanis, Basilea, Cellceutix, Cempra, Cidara, Contrafect, Debiopharm, Geom, GlaxoSmithKline, Insmed, Kalya, Medicines Company, Meiji, Melinta, Merck, Nabriva, Nexcida, Northern Antibiotics, Novartis, Paratek, PolyPhor, Roche, Spero, Takeda, Theravance, Tetraphase, VenatoRx, Wockhardt, and Zavante. H. F. C. receives grant support from Genentech and Allergan. R. H. E. is a patentee on antibacterial drug development, a consultant to Genomatica, and a biomedical experts panel member for the, Skolkovo Foundation. A. J. is an employee of the Infectious Diseases Society of America. B. E. M. receives grant support from Merck, Theravance, and Actavis and is a consultant for Cempra and Paratek. J. G. N. is a consultant for RPS Diagnostics. J. H. R. is chief strategy officer for CARB-X, chief medical officer and director for F2G, nonexecutive director and consultant for Adenium Biotech, operating partner and consultant for Advent Life Sciences, and expert-in-residence for Wellcome Trust; is on the scientific advisory boards of Macrolide Pharmaceuticals, Spero Therapeutics, and Bugworks Research; is a shareholder in AstraZeneca Pharmaceuticals, F2G, Adenium Biotech, Advent Life Sciences, Macrolide Pharmaceuticals, and Bugworks Research; and has received consulting fees from Phico Therapeutics, ABAC Therapeutics, Polyphor, Heptares Therapeutics, and Ganagen. B. O. reports no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Publisher Copyright: {\textcopyright} The Author 2017.",
year = "2017",
month = jul,
day = "15",
doi = "10.1093/infdis/jix211",
language = "English (US)",
volume = "216",
pages = "228--236",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "2",
}
