P-1209. Efficacy of β-lactam Enhancer Based Zidebactam-Cefepime Combination (WCK 5222) versus Meropenem in Adults with Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) in a Global, Randomized, Double-blind, Phase 3 Trial
Abstract
Abstract Background The combination of β-lactam enhancer zidebactam and cefepime (ZID-FEP) is in development for the treatment of diverse infections caused by a wide range of MDR/XDR Gram-negative bacteria including MBL-producers. In a registration-enabling Phase 3 study (ENHANCE), efficacy and safety of ZID-FEP was compared against meropenem in adults with cUTI or AP. Clinical cure, microbiological eradication and overall success rates at test-of-cure visit in mMITT population Methods This Phase 3, randomized, double-blind, active-controlled and non-inferiority trial was conducted at 44 global sites across U.S., EU, India, Mexico, and China, enrolling hospitalized adults (≥18 years old) with a clinical diagnosis of cUTI or AP ± concurrent bacteremia. Eligible patients were randomized 2:1 to receive ZID-FEP 1+ 2 g (1 h infusion) or meropenem 1 g (0.5 h infusion) for 7 to 10 days with dosage adjustments based on renal function. The primary efficacy outcome (FDA & EMA endpoint) was the proportion of patients in the Microbiological Modified Intent-To-Treat (mMITT) population who achieved overall success (clinical cure combined with microbiological eradication) at the test-of-cure (TOC) visit (Day 17±2). The non-inferiority margin was -15.0% and a pre-specified test for superiority for the primary endpoint was performed in the expanded-mMITT (e-mMITT) population following confirmation of non-inferiority (NCT04979806). Results Of the 529 patients randomized and treated (352 in…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 529 participants or records.
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