A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients
NCT ID: NCT01234831
Last Updated: 2017-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
463 participants
INTERVENTIONAL
2010-12-31
2016-03-31
Brief Summary
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Detailed Description
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MRSA status is a determinant of bed allocation, especially in shared-room settings, which represent the most common organization in the US and globally. Based on guidelines from the Centers for Disease Control and Prevention, once patients are designated as having had a positive MRSA culture (either colonized or from a clinical isolate), they require Contact Precautions. This requirement translates into either cohorting with other patients with similar precautions status (i.e., two patients with MRSA share a room) or placement in a private room in the hospital. Cohorting is not the preferred infection control method, but in shared-room settings, it is the most common scenario, particularly in hospitals with high occupancy.
Individuals can clear MRSA colonization spontaneously. In fact, up to 38% of patients with MRSA-positive cultures taken greater than 3 months prior were found to be MRSA-negative during a re-screening program conducted by the Massachusetts General Hospital Infection Control Unit from 2004-2006. Other studies have demonstrated that a majority of patients are likely to clear colonization at various time points from original documentation of MRSA infection or colonization. There is currently no standardized approach or accepted guidelines for addressing screening for clearance of colonization in the growing pool of patients who have previous MRSA colonization/infection. Many organizations do provide guidelines for screening, but these guidelines are not based on rigorous study, have a variety of permutations, and have neither consensus acceptance nor adequate implementation among the medical community.
The status quo limits bed availability and delays patient discharge to rehabilitation facilities, adversely affecting quality and efficiency, and resulting in use of additional hospital resources. In addition to problems associated with patient flow for admissions and discharges, precaution status results in additional disruptions of patient care through "bed moves" to accommodate the use of shared rooms by like patients needing Contact Precautions.
A patient's precaution status affects his/her care from admission through discharge. During pre-admission, patients identified as previously having MRSA are affected by bed shortages and delays to admission while in emergency departments. While admitted, under current practices, patients who have in fact cleared MRSA may be cohorted with those who have active infection or persistent colonization, putting them at risk of recolonization and hospital acquired infection (HAI). Finally, patients who are on precautions for MRSA often have delayed discharge to rehabilitation or nursing facilities because of bed constraints similar to those experienced by acute care facilities.
We hypothesize that the use of more sensitive Polymerase Chain Reaction (PCR) methods detecting MRSA in nasal swabs can facilitate identification of true negative patients and can reliably do so with a single negative test in a shorter period of time, thereby greatly facilitating the ability to complete testing on a larger proportion of patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Active Screening
Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
nucleic acid amplification of nasal swab; nasal swab culture
Nasal swab is performed and analyzed using nucleic acid amplification to determine the presence or absence of MRSA DNA. One nasal swab is performed each day for three consecutive days during hospitalization.
Passive Screening
Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
Nasal swab culture
Nasal swabs are obtained if the clinician caring for the patient identifies the patient as eligible to be screened for colonization. An algorithm for screening eligible patients is available electronically as part of the patient's standard medical record to the clinicians providing care.
Interventions
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nucleic acid amplification of nasal swab; nasal swab culture
Nasal swab is performed and analyzed using nucleic acid amplification to determine the presence or absence of MRSA DNA. One nasal swab is performed each day for three consecutive days during hospitalization.
Nasal swab culture
Nasal swabs are obtained if the clinician caring for the patient identifies the patient as eligible to be screened for colonization. An algorithm for screening eligible patients is available electronically as part of the patient's standard medical record to the clinicians providing care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* last positive MRSA culture greater than 3 months old
* admitted to hospital
Exclusion Criteria
* last positive MRSA culture less than or equal to 3 months old
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Erica S. Shenoy
Assistant Chief, Infection Control Unit
Principal Investigators
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David C Hooper, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Erica S Shenoy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Shenoy ES, Noubary F, Kim J, Rosenberg ES, Cotter JA, Lee H, Walensky RP, Hooper DC. Concordance of PCR and culture from nasal swabs for detection of methicillin-resistant Staphylococcus aureus in a setting of concurrent antistaphylococcal antibiotics. J Clin Microbiol. 2014 Apr;52(4):1235-7. doi: 10.1128/JCM.02972-13. Epub 2014 Jan 22.
Shenoy ES, Kim J, Rosenberg ES, Cotter JA, Lee H, Walensky RP, Hooper DC. Discontinuation of contact precautions for methicillin-resistant staphylococcus aureus: a randomized controlled trial comparing passive and active screening with culture and polymerase chain reaction. Clin Infect Dis. 2013 Jul;57(2):176-84. doi: 10.1093/cid/cit206. Epub 2013 Apr 9.
Related Links
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Clin Infect Dis 2013 May 10. \[Epub ahead of print\]
J Clin Microbiol. 2014 Apr;52(4):1235-7. doi: 10.1128/JCM.02972-13. Epub 2014 Jan 22.
Other Identifiers
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2010P001336
Identifier Type: -
Identifier Source: org_study_id