A Multicentre, Parallel Group Open-label Randomised Controlled Non-Inferiority Phase 3 Trial, of Ceftolozane-tazobactam Versus Meropenem for Definitive Treatment of Bloodstream Infection Due to Extended-Spectrum Beta-Lactamase (ESBL) and AmpC-producing Enterobacterales (MERINO III)

NCT04238390 Phase 3 WITHDRAWN

The purpose of this study is to determine whether ceftolozane-tazobactam is as effective as meropenem with respect to 30 day mortality in the treatment of bloodstream infection due to third-generation cephalosporin non-susceptible Enterobacterales or a known chromosomal AmpC-producing Enterobacterales (Enterobacter spp., Citrobacter freundii, Morganella morganii, Providencia spp. or Serratia marcescens).

Details

Lead sponsor	The University of Queensland
Phase	Phase 3
Status	WITHDRAWN
Start date	2022-01
Completion	2024-12

Conditions

• Bacteremia Caused by Gram-Negative Bacteria

Interventions

• Ceftolozane-Tazobactam
• Meropenem

Primary outcomes

• Mortality rate at 30 days — 30 days post randomisation
  To compare the 30-day mortality from day of randomisation of each regimen

Countries

Australia, Italy, Saudi Arabia, Singapore, Spain