RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

Summary

The purpose of this study is to determine whether a new antibiotic, Cefiderocol which works against a wide variety of gram negative bacteria, is equally effective as the antibiotics that are currently used as current standard of care.

Timeline

Start

2019-10-28

Primary completion

2023-11-13

Completion

2024-01-29

Outcome

Met primary endpoint

paper Among patients with a hospital-acquired or health-care-associated Gram-negative bloodstream infection, cefiderocol resulted in non-inferior 14-day mortality compared with standard of care. PMID 41067237 ↗

Publications

• Paterson DL, Sulaiman H, Liu PY, Chatfield MD, Yilmaz M, Salmuna ZN, Mazlan MZ, Anunnatsiri S, Sirijatuphat R, Chotiprasitsakul D, Lye DC, Somani J, Kalimuddin S, Aslan AT, Thamlikitkul V, Lee YT, Yang YS, Lin YT, Ramli WNW, Tseng CH, Archuleta S, Chan YFZ, Forde BM, Wright H, Stewart AG, Ramsay KA, Ling W, Rossi V, Harris-Brown TM, Harris PNA; GAME CHANGER Trial Investigators. Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial. Lancet Infect Dis. 2026 Feb;26(2):148-159. doi: 10.1016/S1473-3099(25)00469-4. Epub 2025 Oct 6.
• Wright H, Harris PNA, Chatfield MD, Lye D, Henderson A, Harris-Brown T, Donaldson A, Paterson DL. Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial. Trials. 2021 Dec 7;22(1):889. doi: 10.1186/s13063-021-05870-w.

Drugs

Indications