Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA

NCT01640886 | Terminated

• 1 other identifier: MP2012-A
• Study Type: observational
• Target: 764
• 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 culture using MicroPhage's bacteriophage-based diagnostic platform.

Conditions

Bacteremia

Keywords

Staphylococcus aureus; methicillin resistant; MRSA; MSSA; Blood Culture; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA

  A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).

  3-4 months

Study Arms (2)

Standard of Care

1. Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.) 2. Comparison to the reference method (30 ug cefoxitin disc diffusion).

KeyPath Test Group

All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.

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

Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types: 1. bioMerieux BacT/Alert Standard Aerobic and Anaerobic 2. bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic

You may qualify if:

• Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
• bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
• bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
• Completion of the KeyPathTM BTA Test on the sample.
• Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.

You may not qualify if:

• Samples from blood culture positives over 24 hours from alarm
• Samples deemed contaminated.
• Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.

Sponsors & Collaborators

• MicroPhage, Inc.: lead

Study Sites (3)

University of Arizona, Infectious Disease Research

Tuscon, Arizona, 85721, United States

Location

UCLA Clinical Laboratory

Los Angeles, California, 90049, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retention of de-identified blood culture specimens only.

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Dipankar Manna, Ph.D.

  MicroPhage, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (3)