NCT00814151

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

Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 712 (actual)
• Sponsor: MicroPhage, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacteremia
• Staphylococcal Infection
• Sepsis
• Infection

Interventions

Type	Name	Description
OTHER	MicroPhage 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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-12-24
• Last updated: 2008-12-24

Locations

3 sites across 1 country: United States