Investigator Driven Randomized Controlled Trial of Cefiderocol Versus Standard Therapy for Healthcare Associated and Hospital Acquired Gram-negative Blood Stream Infection: Study Protocol (the GAME CHANGER Trial)

GAME CHANGER

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.

2019-10-28

2023-11-13

2024-01-29

Completed

Early phase I

513

Inclusion Criteria: 1. Bloodstream infection with a Gram-negative organism from at least one blood culture draw. Bacterial identification to species level will be performed using standard laboratory methods (e.g. MALDI-TOF) and susceptibility testing (e.g. Vitek2). 2. The blood stream infection fulfils the criteria as a hospital acquired or healthcare associated infection as per the following definitions: 1. Hospital acquired - Blood stream infection occurring greater than 48 hours after hospital admission, assessed as symptoms or signs of infection not present at time of hospital admission. 2. Healthcare associated - Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following criteria: i. Participant has an intravascular catheter/line that is the source of infection ii. Attended a hospital or haemodialysis clinic or received intravenous chemotherapy in the previous 30 days iii. were hospitalized in an acute care hospital for two or more days in the previous 90 days iv. resided in a nursing home or long-term care facility v. received intravenous antibiotic therapy at home, wound care or specialized nursing care through a healthcare agency, family or friends; or had self-administered intravenous antibiotic medical therapy in the 30 days before the infection 3. No more than 48 hours has elapsed since the positive blood culture collection. 4. Participant is aged 18 years and over (21 in Singapore) 5. The participant or approved proxy is able to provide informed consent. Exclusion Criteria: 1. Refractory shock or comorbid condition such that patient not expected to survive more than 7 days. 2. Participant with history of moderate to severe hypersensitivity reaction to a cephalosporin. 3. Participant with significant polymicrobial bacteraemia including a significant Gram-positive pathogen (that is, a Gram-positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia). 4. Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed. 5. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion). 6. Known pregnancy or breast-feeding. 7. Participant is receiving peritoneal dialysis. 8. Participant previously randomised in this trial.

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2024-02-13