A randomized non-inferiority study comparing imipenem/cilastatin/relebactam with standard-of-care Gram-negative coverage in cancer patients with febrile neutropenia.

This article reports on a randomized, open-label, single-center non-inferiority trial comparing the safety and efficacy of imipenem/cilastatin/relebactam (IPM/REL), a β-lactam/β-lactamase inhibitor combination, with standard-of-care (SOC) antibiotics (mainly cefepime, piperacillin/tazobactam, or meropenem) for empirical treatment of febrile neutropenia in adult cancer patients. Among 100 enrolled patients, IPM/REL demonstrated a significantly higher favorable clinical response at the end of intravenous therapy (EOIV) compared to SOC (90% vs. 74%; P = 0.042), while microbiological eradication rates and safety profiles were comparable between groups. The study suggests that IPM/REL may offer improved early clinical outcomes without increased adverse events or emergence of resistance, supporting reconsideration of current SOC antibiotics that may inadequately cover extended-spectrum beta-lactamase (ESBL)-producing and carbapenem-resistant Enterobacterales in this vulnerable population.