RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Queensland
• Collaborator: Shionogi
• Treatments: Cephalosporins

Criteria

Inclusion Criteria:

• 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).

• The blood stream infection fulfils the criteria as a hospital acquired or healthcare associated infection as per the following definitions

• 1a 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

• 1b Healthcare associated - Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following criteria

• 2a Patient has an intravascular catheter/line that is the source of infection

• 2b Attended a hospital or haemodialysis clinic or received intravenous chemotherapy in the previous 30 days

• 2c were hospitalized in an acute care hospital for two or more days in the previous 90 days

• 2d resided in a nursing home or long-term care facility

• 2e 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

• 1c OR patient meets the diagnosis of community acquired pneumonia where the Gram-negative organism isolated is considered or proven to be the causative agent of the pneumonia.

• No more than 36 hours has elapsed since the positive blood culture collection.

• Patient is aged 18 years and over (21 in Singapore)

• The patient or approved proxy is able to provide informed consent.

Exclusion Criteria:

• Refractory shock or comorbid condition such that patient not expected to survive more than 7 days

• Patient with history of moderate to severe hypersensitivity reaction to a cephalosporin

• Patient with Gram-positive bacteraemia including a significant Gram-positive pathogen (a Gram-positive skin contaminant in one set of blood cultures may not regarded as significant).

• Where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed.

• Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).

• Known pregnancy or breast-feeding.

• Patient is receiving peritoneal dialysis