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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814151
• Other study ID #: MP-2008B
• Status: Completed
• Phase: N/A
• First received: December 22, 2008
• Last updated: December 23, 2008
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: MicroPhage, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Infection
• Sepsis
• Staphylococcal Infection
• Staphylococcal Infections

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institute	Baltimore	Maryland
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	Evanston Northwestern Healthcare Research Institute	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
MicroPhage, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.		Within 48 hours	No
Secondary	Qualitative feedback on the preliminary MicroPhage test protocol.			No
Secondary	Comparative results to market-available S. aureus / MRSA tests for Blood Culture.		Within 48 hours	No