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

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.

Study Overview

• Status: Completed
• Conditions: Bacteremia
• Intervention / Treatment: Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1165

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital patients with at least one positive blood culture.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care; Current practice methods for the determination of bacteremia, specific to site practice.	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.
Gold Standard ID/AST; Identification of S. aureus: coagulase positive, catalase positive, Staphaurex positive, and PYR negative, if performed). Determination of MRSA:S. aureus gold standard and </=11mm OXA DD or </=21mm CFX DD. Determination of MSSA: S. aureus gold standard and >/=13mm OXA DD or >/=22mm CFX DD.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 </=10mm OXA DD or </=21mm CFX DD) iii) Comparison of the MicroPhage S. aureus/MSSA/MRSA test for identification of S. aureus and determination of MSSA to the gold Standard for MSSA (S. aureus gold standard and >/=13mm OXA DD or >/=22mm CFX DD)	Daily per device protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MicroPhage, Inc.
• Investigators: Principal Investigator: Thomas Kirn, MD.PhD, Rutgers, the State University of New Jersey; Principal Investigator: Chao Qi, PhD, Northwestern Medical School; Principal Investigator: Barth Reller, MD, Duke Medical College; Principal Investigator: Connie Savor-Price, MD, Denver Health

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: August 17, 2010
• First Posted (Estimate): August 18, 2010

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: MRSA; Staphylococcus; aureus; methicillin; resistant; MSSA; Blood Culture; diagnostic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: MP2009-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No