Cefepime-enmetazobactam for complicated urinary tract infections: Redefining ESBL therapy
Abstract
Complicated urinary tract infections (UTIs) caused by extended-spectrum β-lactamase (ESBL)- and AmpC β-lactamase-producing Enterobacterales are increasing in India, driving carbapenem use. Cefepime-enmetazobactam (CPM-EMT), a β-lactamase inhibitor active against class A ESBLs and with partial activity against AmpC, but is inactive against metallo-β-lactamases (MBLs). We conducted a narrative review (2018-2025) of PubMed/MEDLINE, ClinicalTrials.gov, and regulatory sources, prioritising randomised trials, surveillance, pharmacokinetic/pharmacodynamic studies, and antimicrobial stewardship programme (AMSP) guidance, with emphasis on Indian resistance trends. In the Phase 3 ALLIUM trial, CPM-EMT achieved superior overall treatment success versus piperacillin-tazobactam in patients with complicated UTI and acute pyelonephritis, including ESBL subgroups. In vitro, CPM-EMT restores cefepime activity against ESBL-producing Enterobacterales; activity against Pseudomonas aeruginosa is variable and largely cefepime-driven. Safety is similar to cefepime; the risk of neurotoxicity increases with renal impairment, supporting renal dose adjustment and prolonged infusion in augmented renal clearance. CPM-EMT is approved in the United States, European Union, and India. CPM-EMT is a carbapenem-sparing option for ESBL/AmpC complicated UTI when MBL risk is low or excluded by rapid carbapenemase testing and local epidemiology. It is not appropriate for empiric use in haemodynamically unstable…
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