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

NCT ID: NCT01184339

Last Updated: 2010-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-08-31

Brief 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.

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.

Conditions

Bacteremia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of Care

Current practice methods for the determination of bacteremia, specific to site practice.

MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

Intervention Type: DEVICE

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.

MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPhage, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

MicroPhage, Inc.

Principal Investigators

Thomas Kirn, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Chao Qi, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Medical School

Barth Reller, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Medical College

Connie Savor-Price, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Other Identifiers

MP2009-B

Identifier Type: -

Identifier Source: org_study_id