Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Browse trials for

• Bacteremia 297
• Fungemia 32
• Sepsis 2,416
• Disease Susceptibility 37

Keywords

• Bacteremia
• Fungemia
• Bloodstream infection
• susceptibility
• MRSA
• VRE

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's enrollment of 743 is above the median of 156 across 156 interventional studies indexed under Bacteremia.

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Study arms

• Experimental
  Control

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

  Other: Bacterial culture · Other: Susceptibility testing

• Experimental
  FilmArray test

  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 testing · Other: Bacterial culture · Other: Susceptibility testing

• Experimental
  FilmArray plus antimicrobial stewardship

  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 testing · Behavioral: Antimicrobial Stewardship · Other: Bacterial culture · Other: Susceptibility testing

Interventions

• DeviceFilmArray 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.

  Also known as: FilmArray Blood Culture Identification Panel

• BehavioralAntimicrobial Stewardship

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

• OtherBacterial culture

  This test identifies the pathogen responsible for an infection.

• OtherSusceptibility 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.

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.

   Time frame: Approximately 4 days after enrollment

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: Within 14 days after positive blood culture

4. Time to Pathogen Identification

   Time frame: Approximately 14 days after positive blood culture

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

   Time frame: 3 Days after enrollment

6. Length of Entire Hospitalization (Days)

   Time frame: 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.

   Time frame: 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.

   Time frame: Approximately 14 days after positive blood culture

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

   Time frame: 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.

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

Other outcomes

1. Length of Intensive Care Unit Stay

   Time frame: within 14 days of positive blood culture until ICU discharge

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

   Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.

   Time frame: Approximately 30 days after positive blood culture

Baseline characteristics

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 ↗

Individual participant data

Plan to share: No