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

NCT01184339 | Completed DMC

• 1 other identifier: MP2009-B
• Study Type: observational
• Target: 1,165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacteremia

Keywords

Staphylococcus; aureus; methicillin; resistant; MRSA; MSSA; Blood Culture; diagnostic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

  Daily per device protocol

Study Arms (2)

Standard of Care

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

Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture 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

Interventions

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.

Gold Standard ID/AST; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients with at least one positive blood culture.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPhage, Inc.: lead

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Bacteremia; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 18, 2010

Record last verified: 2010-08