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

This study has been terminated.
(Results did not meet study requirements.)
Sponsor:
Information provided by (Responsible Party):
MicroPhage, Inc.
ClinicalTrials.gov Identifier:
NCT01640886
First received: July 12, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Bacteremia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MicroPhage, Inc.:

Primary Outcome Measures:
  • Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]

    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).



Biospecimen Retention:   Samples Without DNA

Retention of de-identified blood culture specimens only.


Enrollment: 764
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640886

Locations
United States, Arizona
University of Arizona, Infectious Disease Research
Tuscon, Arizona, United States, 85721
United States, California
UCLA Clinical Laboratory
Los Angeles, California, United States, 90049
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
MicroPhage, Inc.
Investigators
Principal Investigator: Dipankar Manna, Ph.D. MicroPhage, Inc.
  More Information

No publications provided

Responsible Party: MicroPhage, Inc.
ClinicalTrials.gov Identifier: NCT01640886     History of Changes
Other Study ID Numbers: MP2012-A
Study First Received: July 12, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MicroPhage, Inc.:
Staphylococcus aureus
methicillin resistant
MRSA
 MSSA
Blood Culture
Diagnostic

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013