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

January 14, 2013 updated by: MicroPhage, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

764

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85721
        • University of Arizona, Infectious Disease Research
    • California
      • Los Angeles, California, United States, 90049
        • UCLA Clinical Laboratory
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types:

  1. bioMerieux BacT/Alert Standard Aerobic and Anaerobic
  2. bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Standard of Care
  1. Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.)
  2. Comparison to the reference method (30 ug cefoxitin disc diffusion).
KeyPath Test Group
All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
Time Frame: 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).
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPhage, Inc.

Investigators

  • Principal Investigator: Dipankar Manna, Ph.D., MicroPhage, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP2012-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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