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

Completed

• Conditions: Bacteremia; Infection; Staphylococcal Infection; Sepsis
• Interventions: Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)

• Registration Number: NCT00814151
• Lead Sponsor: MicroPhage, Inc.

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-23
• Last Update Submitted: 2008-12-23
• Study First Posted: 2008-12-24
• Last Update Posted: 2008-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MicroPhage	MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)	Blood Culture positive specimens available within 24 hours of alarm.

Primary Outcome Measures

Name	Time	Method
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.	Within 48 hours

Secondary Outcome Measures

Name	Time	Method
Qualitative feedback on the preliminary MicroPhage test protocol.
Comparative results to market-available S. aureus / MRSA tests for Blood Culture.	Within 48 hours

Trial Locations

Locations (3)

Evanston Northwestern Healthcare Research Institute; 🇺🇸 Evanston, Illinois, United States

Johns Hopkins Medical Institute; 🇺🇸 Baltimore, Maryland, United States

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States