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

NCT00814151 | Completed

• 1 other identifier: MP-2008B
• Study Type: observational
• Target: 712
• Locations: 1 country
• Sites: 3

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.

Conditions

Bacteremia; Staphylococcal Infection; Sepsis; Infection

Keywords

Blood culture; Staphylococcus aureus; Bacteremia; MRSA; MSSA; MicroPhage

Outcome Measures

Primary Outcomes (1)

• Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.

  Within 48 hours

Secondary Outcomes (2)

• Qualitative feedback on the preliminary MicroPhage test protocol.

• Comparative results to market-available S. aureus / MRSA tests for Blood Culture.

  Within 48 hours

Study Arms (2)

MicroPhage

Blood Culture positive specimens available within 24 hours of alarm.

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

Standard of Care

Blood Culture positive specimens.

Interventions

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

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.

MicroPhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Blood culture positive specimens from three academic medical centers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPhage, Inc.: lead

Study Sites (3)

Evanston Northwestern Healthcare Research Institute

Evanston, Illinois, 60201, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Medical Institute

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retention of discrepant blood culture specimens only.

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections; Sepsis; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Study Officials

• J D Smith, Ph.D.

  MicroPhage, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 24, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 24, 2008

Record last verified: 2008-12

Locations

US (3)