Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review

Anthony D Bai; Adam S Komorowski; Carson K L Lo; Pranav Tandon; Xena X Li; Vaibhav Mokashi; Anna Cvetkovic; Aidan Findlater; Laurel Liang; Mark Loeb; Dominik Mertz

doi:10.1128/AAC.01597-20

Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review

Antimicrob Agents Chemother. 2020 Oct 20;64(11):e01597-20. doi: 10.1128/AAC.01597-20. Print 2020 Oct 20.

Authors

Affiliations

¹ Division of Infectious Diseases, McMaster University, Hamilton, Ontario, Canada [email protected].
² Division of Medical Microbiology, McMaster University, Hamilton, Ontario, Canada.
³ Division of Infectious Diseases, McMaster University, Hamilton, Ontario, Canada.
⁴ Global Health Office, McMaster University, Hamilton, Ontario, Canada.
⁵ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Abstract

Novel antibiotics approved by noninferiority trials may become less effective over time in two scenarios: (i) the treatment effect in studies of novel antibiotics may be consistently worse than studies of older antibiotics; (ii) when a decreasingly effective control arm is used in a series of noninferiority trials. Our systematic review of 175 noninferiority antibiotic trials found these scenarios to be rare.

Keywords: anti-infective agents; antibacterial agents; noninferiority trials; systematic review.

Publication types

Systematic Review

MeSH terms

Anti-Bacterial Agents* / therapeutic use

Substances

Anti-Bacterial Agents