BacteremiaNCT01184339
Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
An observational study of Bacteremia, run by MicroPhage, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- MicroPhage S. aureus/MSSA/MRSA Blood Culture Test
- Type of treatment
- Medical device
- How many people
- 1,165 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients with at least one positive blood culture.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- MicroPhage S. aureus/MSSA/MRSA Blood Culture Test
- Keywords
- Staphylococcus, aureus, methicillin, resistant, MRSA, MSSA, Blood Culture, diagnostic
- Medical subject headings
- Bacteremia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPhage S. aureus/MSSA/MRSA Blood Culture TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Current practice methods for the determination of bacteremia, specific to site practice. Receives: 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. Receives: Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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).
Measured: 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.
Measured: 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)
Measured: 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.
Study of MicroPhage Test performance to primary endpoint criteria with one sample per unique subject.
Measured: Daily per device protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPhage, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Kirn, MD.PhD, Principal investigator, Rutgers, The State University of New JerseyChao Qi, PhD, Principal investigator, Northwestern Medical SchoolBarth Reller, MD, Principal investigator, Duke Medical CollegeConnie Savor-Price, MD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184339
- Sponsor's protocol ID
- MP2009-B
- Status last verified
- Aug 2010
- First submitted
- 4 Mar 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
- ClinicalTrials.gov ID
- NCT01184339
- Acronym / sponsor ID
- MP2009-B
- Conditions
- Bacteremia
- Keywords
- Staphylococcus, aureus, methicillin, resistant, MRSA, MSSA, Blood Culture, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- MicroPhage, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture TestCurrent practice methods for the determination of bacteremia, specific to site practice. |
| Gold Standard ID/AST | – | Device: MicroPhage S. aureus/MSSA/MRSA Blood Culture TestIdentification 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients with at least one positive blood culture.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroPhage S. aureus/MSSA/MRSA Blood Culture TestIn vitro diagnostic for the Identification of S. aureus and determination of MSSA or MRSA from a positive blood culture. Approximately 5 hour rapid test. | Device | Gold Standard ID/AST, Standard of Care |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kirn, MD.PhD principal investigator
Rutgers, The State University of New Jersey
Chao Qi, PhD principal investigator
Northwestern Medical School
Barth Reller, MD principal investigator
Duke Medical College
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by MicroPhage, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Daily per device protocol). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2010.