2893 A. Efficacy and Safety of Aztreonam-Avibactam for the Treatment of Serious Infections Due to Gram-Negative Bacteria, Including Metallo-β-Lactamase-Producing Pathogens: Phase 3 REVISIT Study

Abstract

Background. Multidrug resistant (MDR) Gram-negative bacteria, including metallo-β-lactamase (MBL) producers, pose significant treatment challenges. This study investigated efficacy and safety of aztreonam-avibactam (ATM-AVI) in the treatment of complicated intra-abdominal infection (cIAI) or hospital-acquired)/ ventilator-associated pneumonia (HAP/VAP) due to Gram-negative bacteria, including MBL-producing MDR pathogens, with limited or no treatment options. Methods. REVISIT was a phase 3, prospective, randomized, multicenter, open-label, central assessor-blinded study in hospitalized adults. Patients were randomized 2:1 to ATM-AVI (± metronidazole [MTZ]; cIAI patients only) or meropenem (MER) ± colistin (COL) for 5-14 (cIAI) or 7-14 (HAP/VAP) days. Clinical cure at the test-of-cure (TOC) visit in the intent-to-treat (ITT) and clinically evaluable (CE)