BacteremiaNCT00814151
MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
An observational study of Bacteremia and Staphylococcal Infection, 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 cultures by 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, Staphylococcal Infection, Sepsis
- What is being tested?
- MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)
- How many people
- 712 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Dec 2008
- 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: Blood culture positive specimens from three academic medical centers.
Who may be able to join
- Over 18 years of age.
- Blood culture positive, of ANY of the following bottle types:
- BD Bactec Standard Aerobic and Anaerobic,
- BD Bactec Plus Aerobic and Anaerobic,
- bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
- bioMerieux BacT/Alert FAN Aerobic and Anaerobic.
Who cannot join
- BD Bactec Lytic, Pediatric, or other bottle types not listed above.
- bioMerieux Pediatric FAN or other bottle types listed above.
- Trek bottles.
- Specimens from patients under 18 years of age.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287
Evanston Northwestern Healthcare Research Institute
Evanston, Illinois, 60201
About this study
Official title: Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
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.
Read the detailed description
This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.
- Conditions
- Bacteremia, Staphylococcal Infection, Sepsis, Infection
- Being tested
- MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)
- Keywords
- Blood culture, Staphylococcus aureus, Bacteremia, MRSA, MSSA, MicroPhage
- Medical subject headings
- Bacteremia, Staphylococcal Infections, Sepsis, Infections
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 Test (prototype)Other
In vitro diagnostic: The MicroPhage "Intervention" was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The "Intervention" results were not made available to the patient or their physician.
| Study group | Role | What they receive |
|---|---|---|
| MicroPhage | Blood Culture positive specimens available within 24 hours of alarm. Receives: Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype) | |
| Standard of Care | Blood Culture positive specimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
Measured: Within 48 hours
Secondary outcomes (2)
Qualitative feedback on the preliminary MicroPhage test protocol.
Comparative results to market-available S. aureus / MRSA tests for Blood Culture.
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPhage, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J D Smith, Ph.D., Principal investigator, MicroPhage, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814151
- Sponsor's protocol ID
- MP-2008B
- Status last verified
- Dec 2008
- First submitted
- 22 Dec 2008
- Last updated
- 24 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
- ClinicalTrials.gov ID
- NCT00814151
- Acronym / sponsor ID
- MP-2008B
- Conditions
- Bacteremia, Staphylococcal Infection, Sepsis, Infection
- Keywords
- Blood culture, Staphylococcus aureus, Bacteremia, MRSA, MSSA, MicroPhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- MicroPhage, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Dec 2008 (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 cultures by MicroPhage's bacteriophage-based diagnostic platform.
Detailed description
This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroPhage | – | Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)Blood Culture positive specimens available within 24 hours of alarm. |
| Standard of Care | – | –Blood Culture positive specimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Blood culture positive specimens from three academic medical centers.
Key inclusion criteria (6 listed)
- Over 18 years of age.
- Blood culture positive, of ANY of the following bottle types:
- BD Bactec Standard Aerobic and Anaerobic,
- BD Bactec Plus Aerobic and Anaerobic,
- bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
Key exclusion criteria (4 listed)
- BD Bactec Lytic, Pediatric, or other bottle types not listed above.
- bioMerieux Pediatric FAN or other bottle types listed above.
- Trek bottles.
- Specimens from patients under 18 years of age.
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 Test (prototype)In vitro diagnostic: The MicroPhage "Intervention" was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The "Intervention" results were not made available to the patient or their physician. | Other | MicroPhage |
Primary outcome
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
Time frame: Within 48 hours
2 secondary outcomes
Qualitative feedback on the preliminary MicroPhage test protocol.
Comparative results to market-available S. aureus / MRSA tests for Blood Culture.
Time frame: Within 48 hours
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 24 Dec 2008.
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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.
J D Smith, 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 and Staphylococcal Infection, 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 6 inclusion and 4 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 24 Dec 2008. 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 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 clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. (time frame: Within 48 hours). 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 24 Dec 2008; AzTrials last refreshed its copy on 6 Nov 2026.