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

NCT ID: NCT00814151

Last Updated: 2008-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

712 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Bacteremia Staphylococcal Infection Sepsis Infection

Keywords

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Blood culture Staphylococcus aureus Bacteremia MRSA MSSA MicroPhage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MicroPhage

Blood Culture positive specimens available within 24 hours of alarm.

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

Intervention Type 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.

Standard of Care

Blood Culture positive specimens.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPhage, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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MicroPhage, Inc.

Principal Investigators

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J D Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

MicroPhage, Inc.

Locations

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Evanston Northwestern Healthcare Research Institute

Evanston, Illinois, United States

Site Status

University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status

Johns Hopkins Medical Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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MP-2008B

Identifier Type: -

Identifier Source: org_study_id