Staphylococcus Aureus InfectionsNCT02027389
Impact of Rapid Detection of MRSA
An observational study of Staphylococcus Aureus Infections, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of this study is to evaluate the impact of the Alere\™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Aureus Infections
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures between Sept 15, 2012 - Dec 31, 2012 (control) and Sept 15, 2013 - Dec 31, 2013 (intervention)
Who may be able to join
- Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures (both control and intervention periods)
- Above, with rapid PBP2a testing (intervention period only).
Who cannot join
- Patients with polymicrobial cultures (i.e., growth of S. aureus plus other organisms in the culture).
- Patients who have not provided MN authorization to use their medical records for research.
- Patients who have had the FilmArray Blood culture identification diagnostic test performed on an index S. aureus blood culture.
- Patients who have had a sterile source S. aureus culture within the prior 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere™ PBP2a)
The objective of this study is to evaluate the impact of the Alere\™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.
- Conditions
- Staphylococcus Aureus Infections
- Keywords
- MSSA, MRSA
- Medical subject headings
- Staphylococcal Infections
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 |
|---|---|---|
| control | Patients with growth of S. aureus from sterile site cultures between Sept 15, 2012 - Dec 31, 2012. No rapid testing was performed, and standard bacterial culture and susceptibility testing was done. | |
| intervention | Patients with growth of S. aureus from sterile site cultures between Sept 15, 2013 - Dec 31, 2013. Rapid PBP2a testing was performed along with pharmacist notification of service if modification to therapy needed based on rapid test results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods
Measured: within first 7 days of culture result
Secondary outcomes (2)
Time (in hours) to identification of MRSA.
Measured: within first 3 days of culture result
Vancomycin days of therapy following S. aureus culture result
Measured: during the 2 weeks following culture result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: personnel change, unable to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus InfectionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritu Banerjee, M.D., Ph.D., Mayo Clinic
- Investigators
- Ritu Banerjee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027389
- Sponsor's protocol ID
- 13-008045
- Status last verified
- Feb 2018
- First submitted
- 27 Dec 2013
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere™ PBP2a)
- ClinicalTrials.gov ID
- NCT02027389
- Acronym / sponsor ID
- 13-008045
- Conditions
- Staphylococcus Aureus Infections
- Keywords
- MSSA, MRSA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: personnel change, unable to continue study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Jan 2014 (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.
The objective of this study is to evaluate the impact of the Alere\™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –Patients with growth of S. aureus from sterile site cultures between Sept 15, 2012 - Dec 31, 2012. No rapid testing was performed, and standard bacterial culture and susceptibility testing was done. |
| intervention | – | –Patients with growth of S. aureus from sterile site cultures between Sept 15, 2013 - Dec 31, 2013. Rapid PBP2a testing was performed along with pharmacist notification of service if modification to therapy needed based on rapid test results. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures between Sept 15, 2012 - Dec 31, 2012 (control) and Sept 15, 2013 - Dec 31, 2013 (intervention)
Key inclusion criteria (2 listed)
- Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures (both control and intervention periods)
- Above, with rapid PBP2a testing (intervention period only).
Key exclusion criteria (4 listed)
- Patients with polymicrobial cultures (i.e., growth of S. aureus plus other organisms in the culture).
- Patients who have not provided MN authorization to use their medical records for research.
- Patients who have had the FilmArray Blood culture identification diagnostic test performed on an index S. aureus blood culture.
- Patients who have had a sterile source S. aureus culture within the prior 30 days.
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
Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods
Time frame: within first 7 days of culture result
2 secondary outcomes
Time (in hours) to identification of MRSA.
Time frame: within first 3 days of culture result
Vancomycin days of therapy following S. aureus culture result
Time frame: during the 2 weeks following culture result
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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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.
Ritu Banerjee, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Infections, run by Mayo Clinic at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods (time frame: within first 7 days of culture result). 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 13 Feb 2018.