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Methods: ZEUS was a multicenter, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZTI-01 in treatment of hospitalized adults with cUTI or AP versus piperacillin/tazobactam (P-T). The primary endpoint of overall success was defined as clinical cure plus microbiologic eradication in the microbiologic modified intent-to-treat (m-MITT) population at test-of-cure (TOC) visit (Day 19). Patients were randomized to receive 6 g ZTI-01 as 1-hour IV infusion q8h or 4.5 g IV P-T as 1-hour IV infusion q8h for 7 days (up to 14 days if concurrent bacteremia). Clinical cure was defined as complete resolution or significant improvement of signs/symptoms of cUTI or AP present at baseline and no new symptoms, and microbiologic eradication as baseline bacterial pathogen(s) reduced to <104CFU/mL on urine culture and negative on repeat blood culture.

open forum infectious diseases

Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) vs. Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)