6/28/23, 12:07 AM ALLIUM Pathway Feedback Search Clinical Topics Home Studies ALLIUM ALLIUM Disease Disease Acute cystitis Acute pyelonephritis Trial question Is cefepime/enmetazobactam superior to piperacillin/tazobactam in patients with complicated UTI or acute pyelonephritis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.0% female N = 1034 45.0% male 1034 patients (568 female, 466 male) Inclusion criteria: adult patients with a clinical diagnosis of complicated UTI or acute pyelonephritis caused by Gram-negative urinary pathogens Key exclusion criteria: urine culture with gram-positive primary pathogen; hypersensitivity or allergic reaction to trial drugs; weight > 180 kg; life expectancy < 6-week study period Interventions N=516 cefepime/enmetazobactam (cefepime 2 g, enmetazobactam 0.5 g, given by 2-hour infusion every 8 hours for 7 days) N=518 piperacillin/tazobactam (piperacillin 4 g, tazobactam 0.5 g, given by 2-hour infusion every 8 hours for 7 days) https://web.pathway.md/studies/receAxjxK0PCaXtDa 1/2 6/28/23, 12:07 AM ALLIUM Pathway Primary outcome Overall treatment success at day 14 79.1 % 79.1 59.3 % 58.9 39.5 % Significant increase 19.8 % NNT = 5 0.0 % Cefepime/enmetazobactam Piperacillin/tazobactam Significant increase in overall treatment success at day 14 (79.1% vs. 58.9%; AD 21.2%, 95% CI 14.3 to 27.9) Secondary outcomes No significant difference in clinical cure at day 14 (92.5% vs. 88.9%; AD 3.5%, 95% CI -1 to 8) Significant increase in microbiological eradication at day 14 (82.9% vs. 64.9%; AD 19%, 95% CI 12.3 to 25.4) Significant increase in overall success at day 21 (68.4% vs. 58.9%; AD 10.7%, 95% CI 3.4 to 17.8) Safety outcomes No significant difference in treatment-emergent adverse events. Conclusion In adult patients with a clinical diagnosis of complicated UTI or acute pyelonephritis caused by Gram-negative urinary pathogens, cefepime/enmetazobactam was superior to piperacillin/tazobactam with respect to overall treatment success at day 14. Reference Keith S Kaye, Adam Belley, Philip Barth et al. Effect of Cefepime/Enmetazobactam vs Piperacillin/Tazobactam on Clinical Cure and Microbiological Eradication in Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1304-1314. Open reference URL https://web.pathway.md/studies/receAxjxK0PCaXtDa 2/2