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BacteremiaNCT01898208

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

A study testing FilmArray testing, Antimicrobial Stewardship and Bacterial culture in people with Bacteremia and Fungemia, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)? Read more about this study

Who is it for?
Ages Up to 99 years
Conditions the study is for
Bacteremia, Fungemia, Bloodstream Infection
What is being tested?
FilmArray testing, Antimicrobial Stewardship and Bacterial culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
743 participants
Where
1 siteUnited States
Study dates
Aug 2013to Aug 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Positive blood culture during the study period.
  • No positive blood cultures in prior 7 days
  • Minnesota state research authorization provided

Who cannot join

  • No Minnesota state research authorization
  • Deceased or transitioned to comfort care within 24 hours of enrollment
  • Positive blood culture in prior 7 days
  • Previously enrolled in this study
  • Negative Gram stain

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project

Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?

Read the detailed description

We hypothesize that the FilmArray Blood Culture ID Panel will reduce the duration of empiric broad-spectrum antimicrobial therapy typically administered in patients who have positive blood cultures, improving clinical outcome and reducing cost. To test this hypothesis we propose a prospective, randomized controlled study comparing outcomes among patients with positive blood cultures who receive either: Standard culture and antimicrobial susceptibility testing (AST) of positive blood culture bottles as is done today (control), standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel (intervention group 1), or standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel testing along with expert infectious diseases phone consultation (intervention group 2). In both intervention groups, results of the FilmArray test will be communicated by phone to the primary service, along with templated comments about optimal antimicrobial therapy, based on the result. (Templated comments will also be used in the control group). In intervention group 2, an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy, if appropriate, based on microbiology results and clinical information obtained through medical record review and discussion with the primary service.

Being tested
FilmArray testing, Antimicrobial Stewardship, Bacterial culture, Susceptibility testing
Keywords
Bacteremia, Fungemia, Bloodstream infection, susceptibility, MRSA, VRE
Medical subject headings
Bacteremia, Fungemia, Sepsis, Disease Susceptibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilmArray testingDevice

    Also called FilmArray Blood Culture Identification Panel

    FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.

  • Antimicrobial StewardshipBehavioural

    Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.

  • Bacterial cultureOther

    This test identifies the pathogen responsible for an infection.

  • Susceptibility testingOther

    Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.

Study groups in NCT01898208
Study groupRoleWhat they receive
ControlExperimentalStandard Mayo practices (bacterial culture and susceptibility testing) will be used. FilmArray testing will not be performed.
Receives: Other: Bacterial culture; Other: Susceptibility testing
FilmArray testExperimentalStandard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
Receives: Device: FilmArray testing; Other: Bacterial culture; Other: Susceptibility testing
FilmArray plus antimicrobial stewardshipExperimentalStandard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Receives: Device: FilmArray testing; Behavioral: Antimicrobial Stewardship; Other: Bacterial culture; Other: Susceptibility testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Antimicrobial Therapy (Hours)

    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

Secondary outcomes (10)

  1. Time From Positive Gram Stain to First Active Antibiotic

    From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.

    Measured: Approximately 14 days after positive blood culture

  2. Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics

    De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.

    Measured: Positive Gram stain, 96 hours after enrollment

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

    Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.

    Measured: Within 14 days after positive blood culture

  4. Time to Pathogen Identification

    Measured: Approximately 14 days after positive blood culture

  5. Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment

    Measured: 3 Days after enrollment

  6. Length of Entire Hospitalization (Days)

    Measured: Participants were followed for the duration of hospital stay, approximately 15 days

  7. All-cause and Attributable Mortality

    If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.

    Measured: 30 days after positive blood culture

  8. Number of Subjects With Antibiotic-Associated Toxicities/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

  9. Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment

    Measured: Approximately within 72 hours of positive blood culture

  10. Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject

    Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.

    Measured: Approximately 7 days after positive blood culture and for duration of entire hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01898208
Sponsor's protocol ID
11-006920
Other IDs
UM1AI104681, KL2TR000136
Status last verified
Feb 2016
First submitted
8 Jul 2013
Last updated
15 Mar 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.

    PubMed 26197846

Questions about this trial

What is this clinical trial studying?

A study testing FilmArray testing, Antimicrobial Stewardship and Bacterial culture in people with Bacteremia and Fungemia, run by Mayo Clinic at 1 site in United States.

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 5 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: finished, as of the sponsor's last update on 15 Mar 2016. 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Duration of Antimicrobial Therapy (Hours) (time frame: Approximately 4 days after enrollment). 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 NCT01898208, 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 15 Mar 2016.

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