drugset / Trial / NCT04238390

Ceftolozane-tazobactam Versus Meropenem for ESBL and AmpC-producing Enterobacterales Bloodstream Infection

NCT04238390 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2022-01
Primary completion
2024-06
Completion
2024-12

Outcome

Outcome not reported

Stopped: “The decision to withdraw the study was made due to delayed logistics of the supply chain of ceftolozane-tazobactam along with the immense complexities of conducting clinical research felt because of the COVID-19 pandemic.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftolozane Small molecule 2 g Intravenous
Comparator Meropenem Small molecule 1 g Intravenous
Subject Tazobactam Small molecule 1 g Intravenous