title: Noninferior Antibiotics: When Is "Not Bad" "Good Enough"?
abstract: Novel treatment options are urgently needed for patients with serious multidrug-resistant infections seen increasingly in routine everyday clinical practice, both in the hospital and nursing home as well as in the clinic and office setting. Unfortunately, the problem is no longer confined to chronically ill, repeatedly hospitalized patients. This essay explores the role of noninferiorly studies in addressing the pressing need for new antimicrobial agents to combat the emerging "superbugs", calling attention to the nuances of interpreting their sometimes less-than-straightforward results. The overriding aim is not to find better antibiotics for routinely treatable infections but to identify safe and efficacious treatment options where none presently exist.
authors.affiliation: Merck Research Laboratories , Merck & Co., Inc. , Kenilworth, New Jersey.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: DiNubile
keywords: antibiotic resistance; confidence intervals; noninferiority trials