MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial

MicroPhage

Status: Completed

Conditions: Staphylococcal Infection; Infection; Bacteremia; Sepsis

Treatments: Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)

Study type: Observational

Funder types: Industry

Identifiers

NCT00814151

MP-2008B

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 cultures by MicroPhage's bacteriophage-based diagnostic platform.

Full description

This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.

Enrollment: 712 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age.
• Blood culture positive, of ANY of the following bottle types:
• BD Bactec Standard Aerobic and Anaerobic,
• BD Bactec Plus Aerobic and Anaerobic,
• bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
• bioMerieux BacT/Alert FAN Aerobic and Anaerobic.

Exclusion criteria

• BD Bactec Lytic, Pediatric, or other bottle types not listed above.
• bioMerieux Pediatric FAN or other bottle types listed above.
• Trek bottles.
• Specimens from patients under 18 years of age.

Trial design

712 participants in 2 patient groups

MicroPhage

Description:

Blood Culture positive specimens available within 24 hours of alarm.

Treatment:

Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)

Standard of Care

Description:

Blood Culture positive specimens.