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

July 12, 2012
January 14, 2013
June 2012
December 2012   (final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT01640886 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Retention of de-identified blood culture specimens only.

Non-Probability Sample

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
Bacteremia
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
764
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01640886
MP2012-A
No
MicroPhage, Inc.
MicroPhage, Inc.
Not Provided
Principal Investigator: Dipankar Manna, Ph.D. MicroPhage, Inc.
MicroPhage, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP