CompletedPhase 2

RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

Australia513 participantsStarted 2019-10-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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.
✓. Healthcare associated - Blood stream infection present at admission to hospital or within 48 hours of admission in patients that fulfil ANY of following criteria:
✓. No more than 48 hours has elapsed since the positive blood culture collection.
✓. Participant is aged 18 years and over (21 in Singapore)
✓. The participant 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.
✕. Participant with history of moderate to severe hypersensitivity reaction to a cephalosporin.
✕. 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).
✕. 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.
✕. Participant is receiving peritoneal dialysis.
✕. Participant previously randomised in this trial.

What they're measuring

Mortality at 14 days

Timeframe: 14 days post date of randomisation

Trial details

NCT IDNCT03869437

SponsorThe University of Queensland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-13

View on ClinicalTrials.gov More Bloodstream Infections trials