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

This study has been completed.
Sponsor:
Information provided by:
MicroPhage, Inc.
ClinicalTrials.gov Identifier:
NCT00814151
First received: December 22, 2008
Last updated: December 23, 2008
Last verified: December 2008
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MicroPhage, Inc.:

Primary Outcome Measures:
  • Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative feedback on the preliminary MicroPhage test protocol. [ Designated as safety issue: No ]
  • Comparative results to market-available S. aureus / MRSA tests for Blood Culture. [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Retention of discrepant blood culture specimens only.


Enrollment: 712
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814151

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

No publications provided

Responsible Party: Scott Conlin, MicroPhage, Inc.
ClinicalTrials.gov Identifier: NCT00814151     History of Changes
Other Study ID Numbers: MP-2008B
Study First Received: December 22, 2008
Last Updated: December 23, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013