MRSA ColonizationNCT00929435
Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Carriage Rates in Resident Physicians
An observational study of MRSA Colonization, run by University of Oklahoma at 1 site in United States.
Trial summary
One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MRSA Colonization
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All newly recruited residents will be eligible for enrollment.
Who may be able to join
- Study subjects will be newly appointed residents at the OU medical center
Who cannot join
- Previous MRSA infection
- Current use of mupirocin
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma University health science center
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Nasal Carriage Among Resident Physicians
One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be calculated.
Read the detailed description
This is a prospective observational study looking at the incidence of MRSA colonization. New residents will be monitored every month with nasal swabs.We would like to elucidate factors responsible for MRSA colonization in healthcare workers.We would like to see if health care workers who are colonized spontaneously cleared MRSA and if there was any factors involved.
Nasal swabs will be plated on the spot by trained individuals and the plates then incubated for 48 hours. Plates will be read by microbiologist after incubation.
- Conditions
- MRSA Colonization
- Keywords
- MRSA, Contact isolation, Incidence
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 |
|---|---|---|
| MRSA surveillance | Newly recruited resident physicians will be monitored for a year with nasal swabs monthly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect an increase in MRSA nasal carriage rate among newly appointed residents after 1 year of regular patient contact.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Minimal enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA ColonizationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Gary T Kinasewitz, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929435
- Sponsor's protocol ID
- 14684
- Status last verified
- Apr 2012
- First submitted
- 24 Jun 2009
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Nasal Carriage Among Resident Physicians
- ClinicalTrials.gov ID
- NCT00929435
- Acronym / sponsor ID
- 14684
- Conditions
- MRSA Colonization
- Keywords
- MRSA, Contact isolation, Incidence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Minimal enrollment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Jun 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.
One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be calculated.
Detailed description
This is a prospective observational study looking at the incidence of MRSA colonization. New residents will be monitored every month with nasal swabs.We would like to elucidate factors responsible for MRSA colonization in healthcare workers.We would like to see if health care workers who are colonized spontaneously cleared MRSA and if there was any factors involved.
Nasal swabs will be plated on the spot by trained individuals and the plates then incubated for 48 hours. Plates will be read by microbiologist after incubation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRSA surveillance | – | –Newly recruited resident physicians will be monitored for a year with nasal swabs monthly. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All newly recruited residents will be eligible for enrollment.
Key inclusion criteria (1 listed)
- Study subjects will be newly appointed residents at the OU medical center
Key exclusion criteria (2 listed)
- Previous MRSA infection
- Current use of mupirocin
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
To detect an increase in MRSA nasal carriage rate among newly appointed residents after 1 year of regular patient contact.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Minimal enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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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.
Gary T Kinasewitz, MD principal investigator
University of Oklahoma
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 MRSA Colonization, run by University of Oklahoma 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 2 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 9 Apr 2012. 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 stopped early (reason given: Minimal enrollment). 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?
To detect an increase in MRSA nasal carriage rate among newly appointed residents after 1 year of regular patient contact. (time frame: 1 year). 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 9 Apr 2012.