Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 216, Issue 2, Pages 228-236Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jix211
Keywords
antimicrobial resistance; antibiotic development
Categories
Funding
- Genentech
- Allergan
- Merck
- Theravance
- Actavis
- Phico Therapeutics
- ABAC Therapeutics
- Polyphor
- Heptares Therapeutics
- Ganagen
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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.
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