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

Brad Spellberg, Eric P. Brass, John S. Bradley, Roger J. Lewis, David Shlaes, Paul G. Ambrose, Anita Das, Helen W. Boucher, Yohei Doi, John G. Bartlett, Robert A. Bonomo, Steven P. Larosa, George H. Talbot, Daniel Benjamin, Robert Guidos, Amanda Jezek, David N. Gilbert

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1031-1046
Number of pages16
JournalClinical Infectious Diseases
Volume55
Issue number8
DOIs
Publication statusPublished - 15-10-2012

Fingerprint

Clinical Trials
Anti-Bacterial Agents
Infection
Pharmaceutical Preparations
Intraabdominal Infections
Bacteria
Pneumonia

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Spellberg, Brad ; Brass, Eric P. ; Bradley, John S. ; Lewis, Roger J. ; Shlaes, David ; Ambrose, Paul G. ; Das, Anita ; Boucher, Helen W. ; Doi, Yohei ; Bartlett, John G. ; Bonomo, Robert A. ; Larosa, Steven P. ; Talbot, George H. ; Benjamin, Daniel ; Guidos, Robert ; Jezek, Amanda ; Gilbert, David N. / 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. In: Clinical Infectious Diseases. 2012 ; Vol. 55, No. 8. pp. 1031-1046.
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Spellberg, B, Brass, EP, Bradley, JS, Lewis, RJ, Shlaes, D, Ambrose, PG, Das, A, Boucher, HW, Doi, Y, Bartlett, JG, Bonomo, RA, Larosa, SP, Talbot, GH, Benjamin, D, Guidos, R, Jezek, A & Gilbert, DN 2012, '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', Clinical Infectious Diseases, vol. 55, no. 8, pp. 1031-1046. https://doi.org/10.1093/cid/cis688

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. / Spellberg, Brad; Brass, Eric P.; Bradley, John S.; Lewis, Roger J.; Shlaes, David; Ambrose, Paul G.; Das, Anita; Boucher, Helen W.; Doi, Yohei; Bartlett, John G.; Bonomo, Robert A.; Larosa, Steven P.; Talbot, George H.; Benjamin, Daniel; Guidos, Robert; Jezek, Amanda; Gilbert, David N.

In: Clinical Infectious Diseases, Vol. 55, No. 8, 15.10.2012, p. 1031-1046.

Research output: Contribution to journalArticle

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