| Title {1}d | 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 |
| Trial registration {2a and 2b}. | ClinicalTrials.gov identifier: NCT04238390 |
| Protocol version {3} | Version 3, 17th of February 2020 |
| Funding {4} | Merck Sharp & Dohme (Australia) Pty Limited investigator Initiated Funding. |
| Author details {5a} |
Adam G Stewart1,2, Patrick NA Harris1,3, Mark D Chatfield1, Roberta Littleford1, David L Paterson1,2 1Centre for Clinical Research, Faculty of Medicine, University of Queensland, Royal Brisbane and Women’s Hospital Campus, Brisbane, Queensland, Australia 2Department of Infectious Diseases, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia 3Department of Microbiology, Pathology Queensland, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia |
| Name and contact information for the trial sponsor {5b} |
University of Queensland St Lucia Queensland Australia, 4072 |
| Role of sponsor {5c} |
The study sponsor is the University of Queensland. The Principal Investigator and the research team (authors) are responsible for the study design, collection, management, analysis, and interpretation of data and writing of the report or publication. The sponsor and the funder have no role in the study conduct, analysis and interpretation of the findings, and dissemination of the results. |