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

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ClinicalTrials.gov Identifier: NCT00814151
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : December 24, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Bacteremia Staphylococcal Infection Sepsis Infection Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)

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
Actual Enrollment : 712 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
Study Start Date : July 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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

Biospecimen Retention:   Samples Without DNA
Retention of discrepant blood culture specimens only.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Blood culture positive specimens from three academic medical centers.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814151


Locations
United States, Illinois
Evanston Northwestern Healthcare Research Institute
Evanston, Illinois, United States, 60201
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
MicroPhage, Inc.
Investigators
Principal Investigator: J D Smith, Ph.D. MicroPhage, Inc.

Responsible Party: Scott Conlin, MicroPhage, Inc.
ClinicalTrials.gov Identifier: NCT00814151     History of Changes
Other Study ID Numbers: MP-2008B
First Posted: December 24, 2008    Key Record Dates
Last Update Posted: December 24, 2008
Last Verified: December 2008

Keywords provided by MicroPhage, Inc.:
Blood culture
Staphylococcus aureus
Bacteremia
MRSA
MSSA
MicroPhage

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections