Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT)

Summary

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.

Conditions

• Bacteremia
• Sepsis
• Fungemia
• Blood Stream Infection

Interventions

DEVICE

Filmarray Blood Culture ID (BCID) panel

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 KPC carbapenemase) directly from positive blood cultures in \< 1 - 1.5 hours

DEVICE

Rosco Diagnostica ESBL/carbapenemase screen kit

These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for extended-spectrum beta-lactamase / carbapenemase detection from both blood cultures and cultured bacterial colonies.

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• Tan Tock Seng Hospital

  lead OTHER

Principal Investigators

• Shawn Vasoo, MD · Tan Tock Seng Hospital

• Partha P De, MD · Tan Tock Seng Hospital

• Christine B Teng, MSc · National University of Singapore/Tan Tock Seng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

103 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-20

Primary Completion

2019-07-02

Completion

2020-07-02

FDA Device

Yes

Countries

• Singapore

Study Locations