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

December 23, 2008 updated by: MicroPhage, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

712

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Blood culture positive specimens from three academic medical centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MicroPhage
Blood Culture positive specimens available within 24 hours of alarm.
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.
Standard of Care
Blood Culture positive specimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
Time Frame: Within 48 hours
Within 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPhage, Inc.

Investigators

  • Principal Investigator: J D Smith, Ph.D., MicroPhage, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (ESTIMATE)

December 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2008

Last Update Submitted That Met QC Criteria

December 23, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-2008B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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