A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults (OP0595-5)

Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)

The primary efficacy endpoint is the proportion of patients who achieve composite clinical and microbiological success at TOC (Test of Cure visit) in the Microbiological Modified Intent-to-Treat (m MITT) Population. Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.

The secondary efficacy endpoints for cUTI and AP include the following:, The proportion of patients with composite clinical and microbiological success at TOC in the Clinically Evaluable (CE) and Microbiologically Evaluable (ME) Populations;, The proportion of patients with composite clinical and microbiological success at EA, EOT, and FUP in the m MITT Population;, The proportion of patients with a microbiological outcome of eradication at EA, EOT, TOC, and FUP in the m MITT Population and at TOC in the ME Population;, The proportion of patients with a clinical outcome of cure at EA, EOT, TOC, and FUP in the m MITT Population and at TOC in the CE and ME Populations;, The proportion of patients with a clinical outcome of cure at EA, EOT, TOC, and FUP in the m-MITT Population and at TOC in the CE and ME Populations and microbiological outcome of eradication at EA, EOT, TOC, and FUP in the m-MITT Population and at TOC in the ME Population per type of pathogen, type of resistance, and antimicrobial susceptibility; and, The proportion of patients with composite clinical outcome of recurrence and/or microbiological outcome of recurrence at the FUP in the m-MITT, CE, and ME population., The secondary efficacy endpoints for secondary bacteremia include the following:, The proportion of patients with composite clinical and microbiological success of cUTI or AP at TOC in the m-MITT, CE, and ME Populations;, The proportion of patients with a clinical outcome of cure from cUTI or AP at TOC in the m-MITT, CE, and ME Populations;, The proportion of patients with a microbiological outcome of eradication from cUTI or AP at TOC in the m-MITT and ME Populations;, The proportion of patients with a clinical outcome of cure from secondary bacteremia at TOC in the m-MITT, CE, and ME Populations;, The proportion of patients with a microbiological outcome of eradication from secondary bacteremia at TOC in the m-MITT and ME Populations;, The proportion of patients in the m-MITT and ME Populations free from the definition of secondary bacteremia AND a clinical outcome of cure from cUTI or AP AND a microbiological outcome of eradication from cUTI or AP at TOC; and, The proportion of patients who are free from secondary bacteremia at TOC in the m-MITT and ME Populations.

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