Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT)

NCT02743585 | Unknown FDA Device

• 1 other identifier: 2015/00255
• Study Type: interventional
• Target: 832
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time from positive blood culture result to effective/optimal antibiotics

  An effective antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible (or predicted to be susceptible for Candida, per speciation).An optimal antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible/predicted to be susceptible, which is the most narrow spectrum and targeted, as recommended by institutional guidelines. This will be considered as the time from the positive Gram stain to first effective and the first optimal antibiotic.

  Approximately 14 days after positive blood culture

Secondary Outcomes (14)

• Clinical outcome (Infection related mortality)

  1 year

• Clinical outcome (All-cause related mortality)

  1 year

• Clinical outcome (Quality of life)

  1 year

• Time from positive blood culture result to bacterial identification

  Approximately 3 days

• Duration of hospitalization (days)

  Participants were followed for the duration of hospital stay, approximately 28 days

Other Outcomes (7)

• Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics

  Positive Gram stain, 96 hours after enrollment

• Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours

  Within 24 hours after positive blood culture

• Length of Entire Hospitalization (Days)

  Participants are followed for the duration of hospital stay, approximately 15 days

Study Arms (2)

Rapid diagnostic arm

EXPERIMENTAL

Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) AND FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen will be performed. The Interventions to be administered are the rapid diagnostic tests: FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen. Subjects will be recruited 8am-3pm daily, weekdays only. Results of the BCID and Rosco test will be communicated to the managing physicians by phone in real-time.

Device: Filmarray Blood Culture ID (BCID) panel; Device: Rosco Diagnostica ESBL/carbapenemase screen kit

Standard of care (control)

NO INTERVENTION

Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) will be used. FilmArray BCID and Rosco Diagnostica ESBL and carbapenemase screen will NOT be performed. Subjects will be recruited 8am-3pm daily, weekdays only.

Interventions

Filmarray Blood Culture ID (BCID) panel DEVICE

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

Also known as: BCID

Rapid diagnostic arm

Rosco Diagnostica ESBL/carbapenemase screen kit DEVICE

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.

Rapid diagnostic arm

Eligibility Criteria

• Age: 21 Years - 103 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years and above to 103 years
• Blood culture flagged positive on automated instrument, with Gram positive, Gram negative bacteria or Yeast on Gram staining (including polymicrobial blood cultures)
• Ability to provide informed consent or ability to obtain informed consent from legal guardian/representative (verbal and written)

You may not qualify if:

• Patients whose blood cultures turn positive, but have no organism seen on Gram stain.
• Patients who have been previously enrolled.
• Patients who withdraw their consent (verbal or written).
• Patients with any positive blood culture in the preceding 7 days.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Mayo Clinic: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (1)

• Ong SWX, Hon PY, Wee SSH, Chia JWZ, Mendis S, Izharuddin E, Lin RJ, Chia PY, Sim RCS, Chen MI, Chow A, Yoong J, Lye DC, Teng CB, Tambyah PA, Banerjee R, Patel R, De PP, Vasoo S. Accuracy of a Rapid Multiplex Polymerase Chain Reaction Plus a Chromogenic Phenotypic Test Algorithm for Detection of Extended-Spectrum beta-Lactamase and Carbapenemase-Producing Gram-Negative Bacilli in Positive Blood Culture Bottles. Clin Infect Dis. 2022 May 30;74(10):1850-1854. doi: 10.1093/cid/ciab848.

  PMID: 34554228 DERIVED

MeSH Terms

Conditions

Bacteremia; Sepsis; Fungemia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Invasive Fungal Infections; Mycoses

Study Officials

• Shawn Vasoo, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Partha P De, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Christine B Teng, MSc

  National University of Singapore/Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 19, 2016
• Study Start: March 20, 2017
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)