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Comment & Response
February 12, 2019

Antibiotics for Ceftriaxone-Resistant Gram-Negative Bacterial Bloodstream Infections

Author Affiliations
  • 1Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  • 2Service de Pharmacologie Médicale, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
JAMA. 2019;321(6):613. doi:10.1001/jama.2018.19349

To the Editor Dr Harris and colleagues conducted a well-designed study investigating whether carbapenems for extended-spectrum β-lactamase–producing enterobacteria could be spared.1 The results should be interpreted with caution.

First, the study failed to demonstrate the noninferiority of piperacillin-tazobactam compared with meropenem but did not demonstrate the superiority of meropenem. The study was stopped at a difference level for the primary outcome of P < .004, although the predefined stopping rule for superiority was a statistically significant difference at a level of P < .001. A superiority study with a bilateral statistical test instead of a noninferiority study with a unilateral statistical test would have been an option but would have increased the number of patients needed.