Once-Daily Plazomicin for Complicated Urinary Tract Infections

Abstract Background The increasing multidrug resistance among gram-negative uropathogens necessitates new treatments for serious infections. Plazomicinis an aminoglycosidewith bactericidal activity against multidrug-resistant (including carbapenem-resistant) Enterobacteriaceae. Methods We randomly assigned 609 patients with complicated urinary tract infections (UTIs), including acute pyelonephritis, in a 1:1 ratio to receive intravenous plazomicin(15 mg per kilogramof body weight once daily) or meropenem(1 g every 8 hours), with optional oral step-down therapy after at least 4 days of intravenous therapy, for a total of 7 to 10 days of therapy. The primary objective was to show the noninferiority of plazomicinto meropenemin the treatment of complicated UTIs, including acute pyelonephritis, with a noninferiority margin of 15 percentage points. The primary end points were composite cure (clinical cure and microbiologic eradication) at day 5 and at the test-of-cure visit (15 to 19 days after initiatio...