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Trial record 1 of 1 for:    NCT00814151
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MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00814151
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : December 24, 2008
Sponsor:
Information provided by:
MicroPhage, Inc.

Tracking Information
First Submitted Date December 22, 2008
First Posted Date December 24, 2008
Last Update Posted Date December 24, 2008
Study Start Date July 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2008)
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. [ Time Frame: Within 48 hours ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 23, 2008)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
Official Title Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Retention of discrepant blood culture specimens only.
Sampling Method Non-Probability Sample
Study Population Blood culture positive specimens from three academic medical centers.
Condition
  • Bacteremia
  • Staphylococcal Infection
  • Sepsis
  • Infection
Intervention 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.
Study Groups/Cohorts
  • MicroPhage
    Blood Culture positive specimens available within 24 hours of alarm.
    Intervention: Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)
  • Standard of Care
    Blood Culture positive specimens.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 23, 2008)
712
Original Actual Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00814151
Other Study ID Numbers MP-2008B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Scott Conlin, MicroPhage, Inc.
Study Sponsor MicroPhage, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: J D Smith, Ph.D. MicroPhage, Inc.
PRS Account MicroPhage, Inc.
Verification Date December 2008