Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA

Bacteremia Clinical Trial

Official title:

Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01640886
• Other study ID #: MP2012-A
• Status: Terminated
• Phase: N/A
• First received: July 12, 2012
• Last updated: January 14, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: MicroPhage, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.

Description:

This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 764
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:

• bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic

• bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic

2. Completion of the KeyPathTM BTA Test on the sample.

3. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.

Exclusion Criteria:

1. Samples from blood culture positives over 24 hours from alarm

2. Samples deemed contaminated.

3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UCLA Clinical Laboratory	Los Angeles	California
United States	University of Arizona, Infectious Disease Research	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MicroPhage, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA	A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex).; ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).	3-4 months	No