White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.
Journal Article (Journal Article)
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.
Full Text
Duke Authors
Cited Authors
- Infectious Diseases Society of America,
Published Date
- October 2012
Published In
- Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Volume / Issue
- 55 / 8
Start / End Page
- 1031 - 1046
PubMed ID
- 22891041
Pubmed Central ID
- PMC3657525
Electronic International Standard Serial Number (EISSN)
- 1537-6591
Digital Object Identifier (DOI)
- 10.1093/cid/cis688
Language
- eng
Conference Location
- United States