1044Efficacy of Ceftolozane/Tazobactam vs Levofloxacin in the Treatment of Complicated Urinary Tract Infections (cUTI) caused by Levofloxacin-resistant Pathogens: Results from the ASPECT-cUTI Trial
Abstract
Background. Ceftolozane/tazobactam demonstrates excellent activity in vitro against Gram-negative pathogens, including extended spectrum β-lactamase–producing Enterobacteriaceae and multidrug-resistant Pseudomonas aeruginosa. The efficacy of ceftolozane/tazobactam in the subset of patients with cUTI, including pyelonephritis, caused by levofloxacin (LVX)-resistant pathogens was examined from pooled efficacy data of 2 Phase 3, randomized, controlled, double-blind trials (NCT01345929 and NCT01345955). Methods. Hospitalized patients ≥18 years old with pyuria and clinical symptoms of cUTI were randomized to either intravenous ceftolozane/tazobactam 1.5 g every 8 hours or intravenous LVX 750 mg/day for 7 days, prior to availability of susceptibility data. Primary outcome was the composite microbiological eradication and clinical cure (composite cure) rate at the test-of-cure (TOC) visit 5-9 days after the end of therapy in the microbiological modified intent-to-treat (mMITT) and microbiologically evaluable (ME) populations. Results. A total of 1083 patients were enrolled, 800 were included in the mMITT population, and 212 had LVX-resistant baseline uropathogens; 176/212 were susceptible to ceftolozane/tazobactam. Ceftolozane/tazobactam demonstrated significantly higher composite cure rates and per-pathogen microbiological eradication rates vs LVX in the mMITT and ME populations (Table). Conclusion. Ceftolozane/tazobactam demonstrated superior composite cure rates vs LVX in cUTI…
How strong is the evidence?
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: 1,083 participants or records.
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