BacteremiaNCT01640886
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
An observational study of Bacteremia, run by MicroPhage, Inc. at 3 sites in United States.
Trial summary
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 764 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Dec 2012
- 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 Gram positive blood cultures determined to be positive with the following bottle types: 1. bioMerieux BacT/Alert Standard Aerobic and Anaerobic 2. bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic
Who may be able to join
- Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
- bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
- bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
- Completion of the KeyPathTM BTA Test on the sample.
- Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.
Who cannot join
- Samples from blood culture positives over 24 hours from alarm
- Samples deemed contaminated.
- Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
UCLA Clinical Laboratory
Los Angeles, California, 90049
University of Arizona, Infectious Disease Research
Tuscon, Arizona, 85721
About this study
Official title: Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
Read the detailed description
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
- Conditions
- Bacteremia
- Keywords
- Staphylococcus aureus, methicillin resistant, MRSA, MSSA, Blood Culture, Diagnostic
- Medical subject headings
- Bacteremia, Staphylococcal Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | 1. Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.) 2. Comparison to the reference method (30 ug cefoxitin disc diffusion). | |
| KeyPath Test Group | All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
- Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by:
- KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Results did not meet study requirements.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPhage, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dipankar Manna, Ph.D., Principal investigator, MicroPhage, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640886
- Sponsor's protocol ID
- MP2012-A
- Status last verified
- Jan 2013
- First submitted
- 12 Jul 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA
- ClinicalTrials.gov ID
- NCT01640886
- Acronym / sponsor ID
- MP2012-A
- Conditions
- Bacteremia
- Keywords
- Staphylococcus aureus, methicillin resistant, MRSA, MSSA, Blood Culture, Diagnostic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Results did not meet study requirements.
- Enrolment
- 764 participants (actual)
- Lead sponsor
- MicroPhage, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2012 (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.
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
Detailed description
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | –1. Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.) 2. Comparison to the reference method (30 ug cefoxitin disc diffusion). |
| KeyPath Test Group | – | –All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types: 1. bioMerieux BacT/Alert Standard Aerobic and Anaerobic 2. bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic
Key inclusion criteria (5 listed)
- Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
- Completion of the KeyPathTM BTA Test on the sample.
- Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.
Key exclusion criteria (3 listed)
- Samples from blood culture positives over 24 hours from alarm
- Samples deemed contaminated.
- Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
Time frame: 3-4 months
A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).
Results and safety
The study was stopped early (reason given: Results did not meet study requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
Related trials for Bacteremia
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
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.
Dipankar Manna, Ph.D. principal investigator
MicroPhage, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by MicroPhage, Inc. at 3 sites in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Results did not meet study requirements.). Results are not available in the source record.
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?
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA (time frame: 3-4 months). 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 15 Jan 2013.