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Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives

NCT01184339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1165

Last updated 2010-08-18

No results posted yet for this study

Summary

Direct 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, two gold-standard reference methods, and two predicate devices with similar indications for use.

Conditions

  • Bacteremia

Interventions

DEVICE

MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

In vitro diagnostic for the Identification of S. aureus and determination of MSSA or MRSA from a positive blood culture. Approximately 5 hour rapid test.

Sponsors & Collaborators

  • MicroPhage, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Kirn, MD.PhD · Rutgers, The State University of New Jersey

  • Chao Qi, PhD · Northwestern Medical School

  • Barth Reller, MD · Duke Medical College

  • Connie Savor-Price, MD · Denver Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-01-31
Completion
2010-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184339 on ClinicalTrials.gov