Bacteremia, Infection, Sepsis, Staphylococcal Infection
Conditions
Keywords
Blood culture, Staphylococcus aureus, Bacteremia, MRSA, MSSA, MicroPhage
Brief summary
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.
Detailed 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.
Interventions
OTHERMicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)
In vitro diagnostic: The MicroPhage Intervention was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The Intervention results were not made available to the patient or their physician.
Sponsors
MicroPhage, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. | Within 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative feedback on the preliminary MicroPhage test protocol. | — |
| Comparative results to market-available S. aureus / MRSA tests for Blood Culture. | Within 48 hours |
Countries
United States
Outcome results
None listed