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

This study has been completed.
Sponsor:
Information provided by:
MicroPhage, Inc.
ClinicalTrials.gov Identifier:
NCT01184339
First received: March 4, 2010
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Bacteremia
Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture Test

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives

Resource links provided by NLM:


Further study details as provided by MicroPhage, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Study of MicroPhage Test performance to primary endpoint criteria with one sample per unique subject.


Biospecimen Retention:   Samples With DNA

Approximately 100 uL of deidentified blood culture sample per test sample run.


Enrollment: 1165
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital patients with at least one positive blood culture.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184339

Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Drew Smith, Ph.D., MicroPhage, Inc.
ClinicalTrials.gov Identifier: NCT01184339     History of Changes
Other Study ID Numbers: MP2009-B
Study First Received: March 4, 2010
Last Updated: August 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by MicroPhage, Inc.:
Staphylococcus
aureus
methicillin
resistant
MRSA
MSSA
Blood Culture
diagnostic

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 23, 2014