Impact of Rapid Detection of MRSA

Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere™ PBP2a)

The objective of this study is to evaluate the impact of the Alere™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.

Study Overview

• Status: Withdrawn
• Conditions: Staphylococcus Aureus Infections

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures between Sept 15, 2012 - Dec 31, 2012 (control) and Sept 15, 2013 - Dec 31, 2013 (intervention)

Description

Inclusion criteria:

1. Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures (both control and intervention periods)
2. Above, with rapid PBP2a testing (intervention period only).

Exclusion criteria:

1. Patients with polymicrobial cultures (i.e., growth of S. aureus plus other organisms in the culture).
2. Patients who have not provided MN authorization to use their medical records for research.
3. Patients who have had the FilmArray Blood culture identification diagnostic test performed on an index S. aureus blood culture.
4. Patients who have had a sterile source S. aureus culture within the prior 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control; Patients with growth of S. aureus from sterile site cultures between Sept 15, 2012 - Dec 31, 2012. No rapid testing was performed, and standard bacterial culture and susceptibility testing was done.
intervention; Patients with growth of S. aureus from sterile site cultures between Sept 15, 2013 - Dec 31, 2013. Rapid PBP2a testing was performed along with pharmacist notification of service if modification to therapy needed based on rapid test results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods	within first 7 days of culture result

Secondary Outcome Measures

Outcome Measure	Time Frame
Time (in hours) to identification of MRSA.	within first 3 days of culture result
Vancomycin days of therapy following S. aureus culture result	during the 2 weeks following culture result

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with MSSA infection who are switched from an MRSA-active drug to an MSSA-active drug .		within 48 hours of Gram-stain result
Duration of bacteremia in patients with MSSA or MRSA bloodstream infections		within first 30 days of culture result
Time to contact isolation in patients with MRSA infections		within first 7 days of culture result
Length of hospitalization		from time of culture result to hospital discharge, an expected average duration of 4 weeks
Total healthcare costs (broken down by bed, laboratory, and pharmacy costs).	participants will be followed for the duration of hospital stay following positive culture result, an expected average of 4 weeks.	from time of culture result to time of hospital discharge, an expected average duration of 4 weeks
Proportion of patients where a electronic (P-care) rule flagged for discordant therapy for the PBP2a result		within first 3 days after culture result
Proportion of patients where the pharmacist contacted the service to modify therapy		wihtin first 7 days after culture result

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ritu Banerjee, MD, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: December 27, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 11, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: MSSA, MRSA
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: 13-008045