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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Disease Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

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.

Primary outcomes

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.

Time frame: Daily per device protocol

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).
Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.

Time frame: Daily per device protocol

Performance comparison of the two tests.
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.

Time frame: Daily per device protocol

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)

Secondary outcomes

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.

Time frame: Daily per device protocol

Study of MicroPhage Test performance to primary endpoint criteria with one sample per unique subject.

Sponsors and collaborators

Lead sponsor

MicroPhage, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 18, 2010
Registry last updated: Aug 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed