Journal
CLINICAL INFECTIOUS DISEASES
Volume 55, Issue 8, Pages 1031-1046Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/cis688
Keywords
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Categories
Funding
- National Institutes of Health
- Cubist
- Pfizer
- Eisai
- The Medicines Company
- Bristol Myers Squibb (BMS)
- GlaxoSmithKline (GSK)
- Meiji
- Polymedix
- Adenium
- Novartis
- Anacor
- Basilea
- multiple institutes of the National Institutes of Health
- Octapharma USA
- Octapharma AG
- Achaogen
- Actelion
- Astellas
- AstraZeneca
- B. Braun Medical
- BMS
- Cempra
- Cerexa
- Durata
- Eli Lilly
- Company
- Elusys
- Therapeutics
- Ferdora Pharmaceuticals
- Forest Research Institute
- Furiex Pharmaceutical
- GSK
- InterMune
- ISMED Inc
- Janssen Research Development
- Kalidex Pharmaceuticals
- Meiji Seika Pharma Co
- Microbiotix
- Nabriva
- Nimbus
- PTC Therapeutics
- Rib-X
- Roche
- Seachaid Pharmaceutical
- Synteract Inc
- Tetraphase
- Zogenix
- Agennix AG
- ExThera Medical
- Actelion, Basilea
- Bayer
- Cubist-Calixa
- FAB Pharma
- JJ, Kalidex
- Merada
- Merck
- Wyeth/Pfizer (DSMB)
- UCB Pharma
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There is a critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria. Traditionally, antibacterial agents have been studied in noninferiority clinical trials that focus on one site of infection (eg, pneumonia, intra-abdominal infection). Conduct of superiority trials for infections caused by highly antibiotic-resistant bacteria represents a new, and as yet, untested paradigm for antibacterial drug development. We sought to define feasible trial designs of antibacterial agents that could enable conduct of superiority and organism-specific clinical trials. These recommendations are the results of several years of active dialogue among the white paper's drafters as well as external collaborators and regulatory officials. Our goal is to facilitate conduct of new types of antibacterial clinical trials to enable development and ultimately approval of critically needed new antibacterial agents.
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