Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Mayo Clinic

Status: Completed

Conditions: Fungemia; Bloodstream Infection; Bacteremia

Treatments: Other: Bacterial culture; Device: FilmArray testing; Behavioral: Antimicrobial Stewardship; Other: Susceptibility testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01898208

UM1AI104681 (U.S. NIH Grant/Contract)

11-006920

KL2TR000136 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)?

Full 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.

Enrollment: 743 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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743 participants in 3 patient groups

Control

Experimental group

Description:

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

Treatment:

Other: Susceptibility testing

Other: Bacterial culture

FilmArray test

Experimental group

Description:

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.

Treatment:

Other: Susceptibility testing

Other: Bacterial culture

Device: FilmArray testing

FilmArray plus antimicrobial stewardship

Experimental group

Description:

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.

Treatment:

Behavioral: Antimicrobial Stewardship

Other: Susceptibility testing

Other: Bacterial culture

Device: FilmArray testing