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Completed

NCT Number: NCT00814151

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infection Staphylococcal Infections Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evanston Northwestern Healthcare Research Institute, Evanston, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MicroPhage, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 24, 2008
Registry last updated
Dec 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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