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

Terminated

• Conditions: Bacteremia

• Registration Number: NCT01640886
• Lead Sponsor: MicroPhage, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 764

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA	3-4 months	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).

Trial Locations

Locations (3)

University of Arizona, Infectious Disease Research; 🇺🇸 Tuscon, Arizona, United States

UCLA Clinical Laboratory; 🇺🇸 Los Angeles, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States