TerminatedNot Applicable

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

Stopped: Results did not meet study requirements.

United States764 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
✓. Completion of the KeyPathTM BTA Test on the sample.
✓. 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

✕. Samples from blood culture positives over 24 hours from alarm
✕. Samples deemed contaminated.
✕. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.

What they're measuring

Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA

Timeframe: 3-4 months

Trial details

NCT IDNCT01640886

SponsorMicroPhage, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Bacteremia trials