BacteremiaRABbITNCT02743585
Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT)
A study testing Filmarray Blood Culture ID (BCID) panel and Rosco Diagnostica ESBL/carbapenemase screen kit in people with Bacteremia and Sepsis, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 103 years
- Conditions the study is for
- Bacteremia, Sepsis, Fungemia
- What is being tested?
- Filmarray Blood Culture ID (BCID) panel and Rosco Diagnostica ESBL/carbapenemase screen kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Mar 2017to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 103 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Hypothesis:
- 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
- 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:
- 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
- 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.
- Conditions
- Bacteremia, Sepsis, Fungemia, Blood Stream Infection
- Being tested
- Filmarray Blood Culture ID (BCID) panel, Rosco Diagnostica ESBL/carbapenemase screen kit
- Medical subject headings
- Bacteremia, Sepsis, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filmarray Blood Culture ID (BCID) panelDevice
Also called BCID
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
Rosco Diagnostica ESBL/carbapenemase screen kitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 14 days after positive blood culture
Secondary outcomes (14)
Clinical outcome (Infection related mortality)
Infection-related at 30-day, 90-days and 1-year
Measured: 1 year
Clinical outcome (All-cause related mortality)
All cause mortality at 30-day, 90-days and 1-year mortality
Measured: 1 year
Clinical outcome (Quality of life)
Quality of life at enrolment, 90-days and at 1 year, as measured by the tools EQ-5D-5L QoL/SF-12
Measured: 1 year
Time from positive blood culture result to bacterial identification
Measured: Approximately 3 days
Duration of hospitalization (days)
Measured: Participants were followed for the duration of hospital stay, approximately 28 days
Duration of bacteremia/fungemia (days)
Measured: Patient-dependent variable, estimated up to 7 days
Time to isolation precautions
Time taken for implementation of appropriate infection control measures (isolation precautions) as appropriate for pathogen detected
Measured: Estimated up to 5 days
Antibiotic-associated adverse events
This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.
Measured: Approximately 14 days after positive blood culture
Antimicrobial utilization (hours/days of therapy)
Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.
Measured: Approximately 4 days after enrollment
Mean Total Hospitalization Costs Per Subject
These will be calculated based on actual billable patient costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Measured: Approximately 7 days after positive blood culture for up to an estimated 24 weeks
Mean Laboratory Costs Per Subject
These will be calculated based on actual billable laboratory costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Measured: Approximately 7 days after positive blood culture for up to an estimated 24 week
Mean Antimicrobials Costs Per Subject
These will be calculated based on actual billable antimicrobial costs (without government subventions/subsidies) following 7 days after the positive blood culture episode and for the duration of hospitalization, up to an estimated 24 weeks.
Measured: Approximately 7 days after positive blood culture and for duration of entire hospitalization
Cost-effectiveness analysis
Incremental cost-effectiveness ratios will be determined by dividing the difference between the average costs of treating a patient in the after phase (C1) and the average cost in the before phase (C0) by the difference between average health outcomes (QALYs) gained in the after phase (O1) and those gained in the before phase (O0). The incremental cost-effectiveness ratio is calculated by the following equation: (C1 - C0)/(O1 - O0). Incremental cost-effectiveness ratios using quality adjusted/sepsis adjusted life years gained as the health outcome of interest will then be determined, based on the method of Jones et al Crit Care Med. 2011 June ; 39(6): 1306-1312.
Measured: Up to 1 year after enrolment and using a 'modeled horizon' based on sepsis-adjusted life expectancies
Time on effective/optimal antibiotics within first 96 hours of positive blood culture
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 in the 96-hour time frame from the positive Gram stain.
Measured: First 96 hours after blood culture turns positive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start20 Mar 2017
- Primary completion2 Jul 2019
- Study completion2 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Shawn Vasoo, Tan Tock Seng Hospital
- Investigators
- Shawn Vasoo, MD, Principal investigator, Tan Tock Seng HospitalPartha P De, MD, Principal investigator, Tan Tock Seng HospitalChristine B Teng, MSc, Principal investigator, National University of Singapore/Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743585
- Sponsor's protocol ID
- 2015/00255
- Other IDs
- 2015
- Acronym
- RABbIT
- Status last verified
- Sep 2019
- First submitted
- 29 Mar 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34554228
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT - Rapid Blood Culture Intervention Trial)
- ClinicalTrials.gov ID
- NCT02743585
- Acronym / sponsor ID
- RABbIT / 2015/00255
- Conditions
- Bacteremia, Sepsis, Fungemia, Blood Stream Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2020 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis:
- 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
- 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:
- 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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid diagnostic arm | Experimental | Device: Filmarray Blood Culture ID (BCID) panel, Device: Rosco Diagnostica ESBL/carbapenemase screen kitStandard 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. |
| 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. |
Who may qualify
- Ages
- 21 to 103 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filmarray Blood Culture ID (BCID) panelAlso: BCIDThe 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 | Rapid diagnostic arm |
| Rosco Diagnostica ESBL/carbapenemase screen kitThese 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. | Device | Rapid diagnostic arm |
Primary outcome
Time from positive blood culture result to effective/optimal antibiotics
Time frame: Approximately 14 days after positive blood culture
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.
14 secondary outcomes
Clinical outcome (Infection related mortality)
Time frame: 1 year
Clinical outcome (All-cause related mortality)
Time frame: 1 year
Clinical outcome (Quality of life)
Time frame: 1 year
Time from positive blood culture result to bacterial identification
Time frame: Approximately 3 days
Duration of hospitalization (days)
Time frame: Participants were followed for the duration of hospital stay, approximately 28 days
Duration of bacteremia/fungemia (days)
Time frame: Patient-dependent variable, estimated up to 7 days
Time to isolation precautions
Time frame: Estimated up to 5 days
Antibiotic-associated adverse events
Time frame: Approximately 14 days after positive blood culture
Antimicrobial utilization (hours/days of therapy)
Time frame: Approximately 4 days after enrollment
Mean Total Hospitalization Costs Per Subject
Time frame: Approximately 7 days after positive blood culture for up to an estimated 24 weeks
Mean Laboratory Costs Per Subject
Time frame: Approximately 7 days after positive blood culture for up to an estimated 24 week
Mean Antimicrobials Costs Per Subject
Time frame: Approximately 7 days after positive blood culture and for duration of entire hospitalization
Cost-effectiveness analysis
Time frame: Up to 1 year after enrolment and using a 'modeled horizon' based on sepsis-adjusted life expectancies
Time on effective/optimal antibiotics within first 96 hours of positive blood culture
Time frame: First 96 hours after blood culture turns positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 34554228Ong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Vasoo, MD principal investigator
Tan Tock Seng Hospital
Partha P De, MD principal investigator
Tan Tock Seng Hospital
Christine B Teng, MSc principal investigator
National University of Singapore/Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filmarray Blood Culture ID (BCID) panel and Rosco Diagnostica ESBL/carbapenemase screen kit in people with Bacteremia and Sepsis, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from positive blood culture result to effective/optimal antibiotics (time frame: Approximately 14 days after positive blood culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.