Sepsis Clinical Trial
Official title:
Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT - Rapid Blood Culture Intervention Trial)
Septic shock carries high mortality, which may be exacerbated by inappropriate initial
therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance.
Conversely, positive blood cultures may result from contamination, leading to unnecessary
therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to
broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility
results.
The investigators hypothesize that rapid identification of pathogens and antimicrobial
resistance will ameliorate the above problems and improve time to optimal therapy, avoid
unnecessary therapy and ultimately improve patient outcomes. While there are a number of
in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical
trials objectively examining the real-world clinical and health-economic impact of such
technology. To date only one randomised trial has been performed in the US
(ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial
resistance. This is a companion study to NCT01898208. The investigators aim to study the
clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance
detection in a setting with a moderate to high levels of antimicrobial resistance.
Hypothesis:
1. Rapid pathogen identification from blood cultures, including early identification of
resistance (via specific genetic markers or phenotypic tests), will allow timelier
initiation of appropriate antibiotic therapy and improved patient outcomes
2. Rapid organism identification from blood cultures will allow timelier initiation of
effective and optimal antibiotic therapy; minimizing the use of unnecessary antibiotics,
including combination therapy
Devices to be studied for this proposed study:
1. BCID panel (Biofire Diagnostics Inc., bioMerieux) : The BCID panel is an FDA-approved
nucleic acid amplification test (based on nested polymerase chain reaction) which
detects Gram positive, Gram negative, the major Candida species and antimicrobial
resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance,
blaKPC for Klebsiella pneumoniae carbapenemase (KPC)) directly from positive blood
cultures in < 1 - 1.5 hours
2. Rosco Diagnostica extended-spectrum beta-lactamase (ESBL) and carbapenemase screen kit
(Rosco Diagnostica): These kits are CE-marked (Approved in the European Union) rapid
chromogenic tests for ESBL/ carbapenemase detection from both blood cultures and
cultured bacterial colonies.
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