Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives

Bacteremia Clinical Trial

Official title:

Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184339
• Other study ID #: MP2009-B
• Status: Completed
• Phase: N/A
• First received: March 4, 2010
• Last updated: August 17, 2010
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: MicroPhage, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Direct 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, two gold-standard reference methods, and two predicate devices with similar indications for use.

Description:

This is a multi-center, FDA clinical study designed to investigate the safety and performance of the MicroPhage S. aureus/MSSA/MRSA test direct from blood culture positives. Informed consent is not anticipated, as this is a laboratory performance study with no patient intervention. The MicroPhage Test will be compared to site standards of care, market-available rapid tests, two predicate tests, and two disk diffusion tests for antimicrobial susceptibility. The study will last approximately 4-6 months (Bactec), dependent on the accrual rate of each institution.

This study is designed to support the following product indications for use:

The MicroPhage S. aureus/MSSA/MRSA Blood Culture Test is a qualitative in vitro diagnostic test for the rapid identification of Staphylococcus aureus and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.

The test uses bacteriophage amplification to rapidly and phenotypically identify the presence of S. aureus and assess the response of the target organism to cefoxitin as an analog to methicillin.

This test is performed on positive blood cultures.

Subculturing of positive blood cultures is necessary for further susceptibility test determinations.

Results of the study analysis will be in the form of descriptive statistics (mean, median, standard deviation, frequencies) for all study variables. Associations among variables will be presented using correlation coefficients, as well as odds ratios and parameter estimates from multivariable regression (linear and logistic) where applicable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1165
• Est. completion date: August 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Blood culture positive samples from subjects aged 18+, with any of the following bottle types:

• BD Bactec Standard Aerobic and Anaerobic,

• BD Bactec Plus Aerobic and Anaerobic,

• Completion of the MicroPhage test protocol on the sample.

Exclusion Criteria:

• Samples from subjects under 18 years of age,

• Samples from any other not included bottle types,

• Samples from blood culture positives over 24 hours from alarm,

• Samples deemed contaminated,

• Mislabeled / misidentified samples or data without documented corrections,

• Violations and/or deviations from the MicroPhage test protocol and/or other included test protocols under study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia

Intervention

Device:
• MicroPhage S. aureus/MSSA/MRSA Blood Culture Test
In vitro diagnostic for the Identification of S. aureus and determination of MSSA or MRSA from a positive blood culture. Approximately 5 hour rapid test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MicroPhage, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.	i) Comparison of the MicroPhage S. aureus/MSSA/MRSA test for identification of S. aureus to the gold Standard for S. aureus (coagulase positive, catalase positive, Staphaurex positive, and PYR negative).	Daily per device protocol	No
Primary	Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.	Performance comparison of the two tests.	Daily per device protocol	No
Primary	Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.	ii) Comparison of the MicroPhage S. aureus/MSSA/MRSA test for identification of S. aureus and determination of MRSA to the gold Standard for MRSA (S. aureus gold standard and	Daily per device protocol	No
Secondary	Determination of clinical performance of the MicroPhage S. aureus/MSSA/MRSA Test to monitor S. aureus/MSSA/MRSA bacteremia clinical blood culture positives with unique subjects.	Study of MicroPhage Test performance to primary endpoint criteria with one sample per unique subject.	Daily per device protocol	No