CompletedNot Applicable

Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives

1,165 participantsStarted 2009-08

Plain-language summary

Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform, two gold-standard reference methods, and two predicate devices with similar indications for use.

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 positive samples from subjects aged 18+, with any of the following bottle types: * BD Bactec Standard Aerobic and Anaerobic, * BD Bactec Plus Aerobic and Anaerobic, * Completion of the MicroPhage test protocol on the sample. Exclusion Criteria: * Samples from subjects under 18 years of age, * Samples from any other not included bottle types, * Samples from blood culture positives over 24 hours from alarm, * Samples deemed contaminated, * Mislabeled / misidentified samples or data without documented corrections, * Violations and/or deviations from the MicroPhage test protocol and/or other included test protocols under study.

What they're measuring

Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.

Timeframe: Daily per device protocol

Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.

Timeframe: Daily per device protocol

Trial details

NCT IDNCT01184339

SponsorMicroPhage, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Bacteremia trials

Plain-language summary

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.

What they're measuring

Timeframe: Daily per device protocol

Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.

Timeframe: Daily per device protocol