Impact of Rapid Detection of MRSA

Staphylococcus Aureus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02027389
• Other study ID #: 13-008045
• Status: Withdrawn
• Phase: N/A
• First received: December 27, 2013
• Last updated: February 11, 2018
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Staphylococcal Infections
• Staphylococcus Aureus Infections

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Duration of bacteremia in patients with MSSA or MRSA bloodstream infections		within first 30 days of culture result
Other	Time to contact isolation in patients with MRSA infections		within first 7 days of culture result
Other	Length of hospitalization		from time of culture result to hospital discharge, an expected average duration of 4 weeks
Other	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
Other	Proportion of patients where a electronic (P-care) rule flagged for discordant therapy for the PBP2a result		within first 3 days after culture result
Other	Proportion of patients where the pharmacist contacted the service to modify therapy		wihtin first 7 days after culture result
Primary	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	Time (in hours) to identification of MRSA.		within first 3 days of culture result
Secondary	Vancomycin days of therapy following S. aureus culture result		during the 2 weeks following culture result