A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David C. Hooper, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01234831
First received: October 28, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
MRSA Colonization
Device: nucleic acid amplification of nasal swab; nasal swab culture
Other: Nasal swab culture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Novel Approach to MRSA Screening of Colonized Patients and Impact on Hospital Resource Allocation and Patient Care

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.

  • Completion of Screening Protocol in Both Trial Arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Rate at which subjects in both trial arms complete the 3-swab protocol.

  • Discontinuation of Contact Precautions in Both Trial Arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Sensitivity of First PCR Assay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.

  • Specificity of First PCR Assay. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Specificity of the first PCR assay for subjects enrolled in active arm of trial.

  • Rate of Recolonization or Documented Infection With MRSA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection.


Enrollment: 463
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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.
Other Names:
  • Cepheid Xpert MRSA
  • BD CHROMagar
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.
Other: 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 Name: BD CHROMagar

Detailed Description:

Compared with patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia, patients with MRSA bacteremia remained in the hospital for two more days on average and had a median attributable increment in hospital charges of approximately $7000.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234831

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David C Hooper, MD Massachusetts General Hospital
Principal Investigator: Erica S Shenoy, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David C. Hooper, Chief, Infection Control Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01234831     History of Changes
Other Study ID Numbers: 2010P001336
Study First Received: October 28, 2010
Results First Received: October 2, 2012
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
MRSA
colonization
nucleic acid amplification
chromogenic agar

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014