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

Description

We are comparing intravenous ceftolozane-tazobactam (new antibiotic) versus meropenem in the treatment of multidrug resistant Gram negative bloodstream infection in adult hospitalised patients with respect to 30 day mortality.

Why are we doing this study?

Bloodstream infections caused by multidrug resistant bacteria have caused many deaths globally. Continued use of “last line” antibiotics to treat these infections have caused an alarming rise in further resistance to these agents. We need to explore alternative treatment options in the form of newly developed antibiotics to prevent this from happening. 

How can people participate?

If people are unwell and admitted to hospital with a bloodstream infection that qualifies for entry into the trial, then they will be approached in hospital by a member of the study team to participate.


Approving HREC: Royal Brisbane & Women’s Hospital HREC (HREC/2019/QRBW/59232)

Funder: Merck Sharp & Dohme (Australia) Pty Ltd

Clinicaltrials.gov (NCT04238390): https://clinicaltrials.gov/ct2/show/NCT04238390?cond=ceftolozane&draw=2&rank=8

Anticipated trial end date: December 2024

Contact

Dr Adam Stewart, Medical Research Fellow

University of Queensland Centre for Clinical Research

adam.stewart@uq.edu.au

+61 7 3346 5555