NCT01898208

Brief 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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
743

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

July 8, 2013

Results QC Date

December 2, 2015

Last Update Submit

February 17, 2016

Conditions

BacteremiaFungemiaBloodstream Infection

Keywords

BacteremiaFungemiaBloodstream infectionsusceptibilityMRSAVRE

Outcome Measures

Primary Outcomes (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.

    Approximately 4 days after enrollment

Secondary Outcomes (10)

  • Time From Positive Gram Stain to First Active Antibiotic

    Approximately 14 days after positive blood culture

  • 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 14 days after positive blood culture

  • Time to Pathogen Identification

    Approximately 14 days after positive blood culture

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

    3 Days after enrollment

  • +5 more secondary outcomes

Other Outcomes (2)

  • Length of Intensive Care Unit Stay

    within 14 days of positive blood culture until ICU discharge

  • Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment

    Approximately 30 days after positive blood culture

Study Arms (3)

Control

EXPERIMENTAL

Standard Mayo practices (bacterial culture and susceptibility testing) will be used. FilmArray testing will not be performed.

Other: Bacterial cultureOther: Susceptibility testing

FilmArray test

EXPERIMENTAL

Standard 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.

Device: FilmArray testingOther: Bacterial cultureOther: Susceptibility testing

FilmArray plus antimicrobial stewardship

EXPERIMENTAL

Standard 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.

Device: FilmArray testingBehavioral: Antimicrobial StewardshipOther: Bacterial cultureOther: Susceptibility testing

Interventions

FilmArray testingDEVICE

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.

Also known as: FilmArray Blood Culture Identification Panel
FilmArray plus antimicrobial stewardshipFilmArray test
Antimicrobial StewardshipBEHAVIORAL

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

FilmArray plus antimicrobial stewardship
Bacterial cultureOTHER

This test identifies the pathogen responsible for an infection.

ControlFilmArray plus antimicrobial stewardshipFilmArray test
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.

ControlFilmArray plus antimicrobial stewardshipFilmArray test

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 26197846RESULT

MeSH Terms

Conditions

BacteremiaFungemiaSepsisDisease Susceptibility

Interventions

Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsInvasive Fungal InfectionsMycosesDisease Attributes

Intervention Hierarchy (Ancestors)

Drug Utilization ReviewDrug UtilizationPharmacy AdministrationOrganization and AdministrationHealth Services AdministrationUtilization ReviewQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Ritu Banerjee, M.D., Ph.D.
Organization
Mayo Clinic
banerjee.ritu@mayo.edu
507-284-6904

Study Officials

  • Robin Patel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Ritu Banerjee, MD, Ph.D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
MD, Ph.D

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 12, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 15, 2016

Results First Posted

March 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)