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

MicroPhage

Status: Terminated

Conditions: Bacteremia

Study type: Observational

Funder types: Industry

Identifiers

NCT01640886

MP2012-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 764 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

764 participants in 2 patient groups

Standard of Care

Description:

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

Description:

All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.