Clinical trial NCT01184339: Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
Official title: Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Keywords: Staphylococcus
aureus
methicillin
resistant
MRSA
MSSA
Blood Culture
diagnostic
Lead sponsor: MicroPhage, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 1165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients with at least one positive blood culture.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Daily per device protocol
measure: Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.
timeFrame: Daily per device protocol
measure: 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.
timeFrame: Daily per device protocol
Secondary outcomes:
measure: 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.
timeFrame: Daily per device protocol
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Thomas Kirn, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Medical School
name: Chao Qi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Medical College
name: Barth Reller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health
name: Connie Savor-Price, MD
role: PRINCIPAL_INVESTIGATOR
References: