Clinical trial NCT02027389: Impact of Rapid Detection of MRSA
Official title: Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere&#8482; PBP2a)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Staphylococcus Aureus Infections
Keywords: MSSA, MRSA
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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)

Brief summary: The objective of this study is to evaluate the impact of the Alere\&#8482; PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.


Eligibility criteria: 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.

Primary outcomes:
measure: Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods
timeFrame: within first 7 days of culture result
Secondary outcomes:
measure: Time (in hours) to identification of MRSA.
timeFrame: within first 3 days of culture result
measure: Vancomycin days of therapy following S. aureus culture result
timeFrame: during the 2 weeks following culture result
Other outcomes:
measure: Proportion of patients with MSSA infection who are switched from an MRSA-active drug to an MSSA-active drug .
timeFrame: within 48 hours of Gram-stain result
measure: Duration of bacteremia in patients with MSSA or MRSA bloodstream infections
timeFrame: within first 30 days of culture result
measure: Time to contact isolation in patients with MRSA infections
timeFrame: within first 7 days of culture result
measure: Length of hospitalization
timeFrame: from time of culture result to hospital discharge, an expected average duration of 4 weeks
measure: Total healthcare costs (broken down by bed, laboratory, and pharmacy costs).
timeFrame: from time of culture result to time of hospital discharge, an expected average duration of 4 weeks
measure: Proportion of patients where a electronic (P-care) rule flagged for discordant therapy for the PBP2a result
timeFrame: within first 3 days after culture result
measure: Proportion of patients where the pharmacist contacted the service to modify therapy
timeFrame: wihtin first 7 days after culture result
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ritu Banerjee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: