Methicillin-Resistant Staphylococcus AureusNCT00996112
Primary Care Management of Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention… Read more about this study
- Who is it for?
- Ages Up to 89 years
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- How many people
- 4,518 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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 Up to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises primary care patients in ambulatory clinics from two health care systems.
Who may be able to join
- All patients presenting at a primary care clinic who have a skin or soft tissue infection.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Management by Primary Care Clinicians of Patients Suspected of Having Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections
The goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary care settings.
- Keywords
- primary health care
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 |
|---|---|---|
| Historical | Not described | |
| Prospective | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Behavior Change
Intervention in practice for guideline-concordant care of CA MRSA
Measured: Throughout study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 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 Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Family Physicians National Research Network
- Responsible party
- Sponsor
- Investigators
- David R West, PhD, Principal investigator, Department of Family Medicine, University of Colorado Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996112
- Sponsor's protocol ID
- 09-0265
- Other IDs
- AHRQ 04-109-6314
- Status last verified
- Nov 2010
- First submitted
- 15 Oct 2009
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management by Primary Care Clinicians of Patients Suspected of Having Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections
- ClinicalTrials.gov ID
- NCT00996112
- Acronym / sponsor ID
- 09-0265
- Keywords
- primary health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,518 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Academy of Family Physicians National Research Network
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Oct 2009 (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 goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical | – | – |
| Prospective | – | – |
Who may qualify
- Ages
- Up to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises primary care patients in ambulatory clinics from two health care systems.
Key inclusion criteria (1 listed)
- All patients presenting at a primary care clinic who have a skin or soft tissue infection.
Key exclusion criteria (1 listed)
- None
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
Physician Behavior Change
Time frame: Throughout study participation
Intervention in practice for guideline-concordant care of CA MRSA
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 25 Jan 2013.
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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.
David R West, PhD principal investigator
Department of Family Medicine, University of Colorado Denver
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 Methicillin-Resistant Staphylococcus Aureus, run by University of Colorado, Denver 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 1 inclusion and 1 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 25 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 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 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?
Physician Behavior Change (time frame: Throughout study participation). 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 25 Jan 2013.