Methicillin-resistant Staphylococcus Aureus InfectionMRSANCT01028105
Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections
A study testing Preoperative MRSA screening in people with Methicillin-resistant Staphylococcus Aureus Infection, run by Inova Health Care Services at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus Infection
- What is being tested?
- Preoperative MRSA screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Oct 2013
- Phase
- Interventional
- 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
Who may be able to join
- Pre-surgical out patient at ILH
- Surgical procedure scheduled at least 2 days before surgery
- Surgery being done at ILH operating room
- Provision of signed ICF
Who cannot join
- Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
- Inability to communicate in the English language
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inova Health Care Services
Falls Church, Virginia, 22042
Inova Loudoun Hospital
Leesburg, Virginia, 20176
About this study
Official title: Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries.
The central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.
Read the detailed description
Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups:
- Group 1 (N=325): Allocation sample of surgical patients required to be MRSA screened per hospital SOP (including patients having a positive MRSA history, orthopedic surgery, undergoing dialysis, or transfer from another hospital, nursing home, skilled nursing facility, or jail).
- Group 2 (N=650): Randomized sample (1:1 ratio) of surgical patients not required to be MRSA screened per hospital SOP, to one of the following two groups:
- 2a (N=325): MRSA screening; or
- 2b (N=325): No MRSA screening. All subjects were followed for 30 days post-operatively to determine the incidence of post-operative infection. Treatment, diagnostic, and hospitalization data were collected for patients diagnosed with post-operative infection.
- Being tested
- Preoperative MRSA screening
- Keywords
- Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MRSA screeningOther
MRSA preoperative screening and post operative infection rate, 30 days post operative
| Study group | Role | What they receive |
|---|---|---|
| No MRSA screening, Group b | No intervention | Standard of care |
| MRSA screening, Group a | Other | MRSA preoperative screening Receives: Other: Preoperative MRSA screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare the prevalence of MRSA colonization and its relationship to post-operative infection in patients who are currently pre-operatively MRSA screened per SOP to those who are not.
Measured: 30 days
Secondary outcomes (1)
The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2011
- Study completionOct 2013
Why it stopped: Enrollment did not reach power, therefore study was administratively closed in 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-resistant Staphylococcus Aureus InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Health
- Responsible party
- Principal investigator, Cynthia Hack, Inova Health Care Services
- Investigators
- Karen G Speroni, BSN, MHSA, PhD, Study director, Inova Loudoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028105
- Sponsor's protocol ID
- 08.003
- Acronym
- MRSA
- Status last verified
- Jun 2021
- First submitted
- 7 Dec 2009
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Methicillin Resistant Staphylococcus Aureus Colonization in Pre-Surgical Patients and Post-Operative Infection
- ClinicalTrials.gov ID
- NCT01028105
- Acronym / sponsor ID
- MRSA / 08.003
- Keywords
- Preoperative screening, MRSA, Incidence, Postoperative infection, Preoperative MRSA Screening Incidence, Postoperative MRSA Infection Rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment did not reach power, therefore study was administratively closed in 2013
- Enrolment
- 975 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Cardinal Health
- Study start
- Feb 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Dec 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 purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries.
The central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.
Detailed description
Design and Methods: Subjects in this study of 975 pre-operative, scheduled surgical patients are in one of the three following groups:
- Group 1 (N=325): Allocation sample of surgical patients required to be MRSA screened per hospital SOP (including patients having a positive MRSA history, orthopedic surgery, undergoing dialysis, or transfer from another hospital, nursing home, skilled nursing facility, or jail).
- Group 2 (N=650): Randomized sample (1:1 ratio) of surgical patients not required to be MRSA screened per hospital SOP, to one of the following two groups:
- 2a (N=325): MRSA screening; or
- 2b (N=325): No MRSA screening. All subjects were followed for 30 days post-operatively to determine the incidence of post-operative infection. Treatment, diagnostic, and hospitalization data were collected for patients diagnosed with post-operative infection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No MRSA screening, Group b | No intervention | –Standard of care |
| MRSA screening, Group a | Other | Other: Preoperative MRSA screeningMRSA preoperative screening |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pre-surgical out patient at ILH
- Surgical procedure scheduled at least 2 days before surgery
- Surgery being done at ILH operating room
- Provision of signed ICF
Key exclusion criteria (2 listed)
- Patient 18 years of age or older who is deemed by the hospital incapable of providing Informed Consent
- Inability to communicate in the English language
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 |
|---|---|---|
| Preoperative MRSA screeningMRSA preoperative screening and post operative infection rate, 30 days post operative | Other | MRSA screening, Group a |
Primary outcome
The primary objective of this study is to compare the prevalence of MRSA colonization and its relationship to post-operative infection in patients who are currently pre-operatively MRSA screened per SOP to those who are not.
Time frame: 30 days
1 secondary outcome
The secondary objective is to compare medical charges associated with diagnosis and treatment of post-operative infections for these groups using cost-effectiveness analysis.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Enrollment did not reach power, therefore study was administratively closed in 2013). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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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.
Karen G Speroni, BSN, MHSA, PhD study director
Inova Loudoun Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative MRSA screening in people with Methicillin-resistant Staphylococcus Aureus Infection, run by Inova Health Care Services at 2 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 4 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: Enrollment did not reach power, therefore study was administratively closed in 2013). 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?
The primary objective of this study is to compare the prevalence of MRSA colonization and its relationship to post-operative infection in patients who are currently pre-operatively MRSA screened per SOP to those who are not. (time frame: 30 days). 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 8 Jun 2021.