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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.

Publication ,  Journal Article
Infectious Diseases Society of America,
Published in: Clin Infect Dis
October 2012

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.

Duke Scholars

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

October 2012

Volume

55

Issue

8

Start / End Page

1031 / 1046

Location

United States

Related Subject Headings

  • Research Design
  • Practice Guidelines as Topic
  • Microbiology
  • Humans
  • Drug Resistance, Bacterial
  • Clinical Trials as Topic
  • Bacterial Infections
  • Anti-Bacterial Agents
  • Animals
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Infectious Diseases Society of America, Ajar. “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.Clin Infect Dis 55, no. 8 (October 2012): 1031–46. https://doi.org/10.1093/cid/cis688.
Infectious Diseases Society of America, Ajar. “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.Clin Infect Dis, vol. 55, no. 8, Oct. 2012, pp. 1031–46. Pubmed, doi:10.1093/cid/cis688.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

October 2012

Volume

55

Issue

8

Start / End Page

1031 / 1046

Location

United States

Related Subject Headings

  • Research Design
  • Practice Guidelines as Topic
  • Microbiology
  • Humans
  • Drug Resistance, Bacterial
  • Clinical Trials as Topic
  • Bacterial Infections
  • Anti-Bacterial Agents
  • Animals
  • 3202 Clinical sciences