MRSA Colonization Clinical Trial
Official title:
A Novel Approach to MRSA Screening of Colonized Patients and Impact on Hospital Resource Allocation and Patient Care
Verified date | September 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings. Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA infections have been associated with high costs and adverse clinic outcomes. Patients can clear MRSA spontaneously. Improved approaches for identifying patients who are no longer colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be used to improve identification of patients who are no longer colonized.
Status | Completed |
Enrollment | 463 |
Est. completion date | March 2016 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age > 18 - last positive MRSA culture greater than 3 months old - admitted to hospital Exclusion Criteria: - age < 18 - last positive MRSA culture less than or equal to 3 months old |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays | This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization. | 1 year | |
Primary | Completion of Screening Protocol in Both Trial Arms | Rate at which subjects in both trial arms complete the 3-swab protocol. | 1 year | |
Primary | Discontinuation of Contact Precautions in Both Trial Arms | Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, "Contact Precautions are discontinued" refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use. | 1 year | |
Secondary | Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay | This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol. | 1 year | |
Secondary | Sensitivity of First PCR Assay | Sensitivity of the first PCR assay for subjects enrolled in active arm of trial. | 1 year | |
Secondary | Specificity of First PCR Assay. | Specificity of the first PCR assay for subjects enrolled in active arm of trial. | 1 year | |
Secondary | Rate of Recolonization or Documented Infection With MRSA | Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included. | 2 years |
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