NCT01898208

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 743 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 99 Years
• Healthy volunteers: Not accepted

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)?

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.

Conditions

• Bacteremia
• Fungemia
• Bloodstream Infection

Interventions

Type	Name	Description
DEVICE	FilmArray testing	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.
BEHAVIORAL	Antimicrobial Stewardship	Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.
OTHER	Bacterial culture	This test identifies the pathogen responsible for an infection.
OTHER	Susceptibility testing	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-07-12
• Last updated: 2016-03-15
• Results posted: 2016-03-15

Locations

1 site across 1 country: United States