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

A Novel Approach to MRSA Screening of Colonized Patients and Impact on Hospital Resource Allocation and Patient Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234831
Enrollment
463
Registered
2010-11-04
Start date
2010-12-31
Completion date
2016-03-31
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRSA Colonization

Keywords

MRSA, colonization, nucleic acid amplification, chromogenic agar

Brief summary

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.

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.

Interventions

DEVICEnucleic 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.

OTHERNasal 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays1 yearThis 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 Arms1 yearRate at which subjects in both trial arms complete the 3-swab protocol.
Discontinuation of Contact Precautions in Both Trial Arms1 yearPatients 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

MeasureTime frameDescription
Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay1 yearThis 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.
Rate of Recolonization or Documented Infection With MRSA2 yearsProspective 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.
Sensitivity of First PCR Assay1 yearSensitivity of the first PCR assay for subjects enrolled in active arm of trial.
Specificity of First PCR Assay.1 yearSpecificity of the first PCR assay for subjects enrolled in active arm of trial.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
261
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.
202
Total463

Baseline characteristics

CharacteristicPassive ScreeningActive ScreeningTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
106 Participants135 Participants241 Participants
Age, Categorical
Between 18 and 65 years
96 Participants126 Participants222 Participants
Age, Continuous62.9 years
STANDARD_DEVIATION 18.45
63.9 years
STANDARD_DEVIATION 16.77
63.47 years
STANDARD_DEVIATION 17.51
Region of Enrollment
United States
202 participants261 participants463 participants
Sex: Female, Male
Female
86 Participants91 Participants177 Participants
Sex: Female, Male
Male
116 Participants170 Participants286 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 463
serious
Total, serious adverse events
0 / 463

Outcome results

Primary

Completion of Screening Protocol in Both Trial Arms

Rate at which subjects in both trial arms complete the 3-swab protocol.

Time frame: 1 year

Population: Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.

ArmMeasureValue (NUMBER)
Active ScreeningCompletion of Screening Protocol in Both Trial Arms73.7 percentage of subjects completed 3 swabs
Passive ScreeningCompletion of Screening Protocol in Both Trial Arms9.6 percentage of subjects completed 3 swabs
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.

Time frame: 1 year

Population: Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.

ArmMeasureValue (NUMBER)
Active ScreeningDiscontinuation of Contact Precautions in Both Trial Arms55.2 percentage of MRSA CP discontinued
Passive ScreeningDiscontinuation of Contact Precautions in Both Trial Arms86.7 percentage of MRSA CP discontinued
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.

Time frame: 1 year

Population: Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.

ArmMeasureValue (NUMBER)
Active ScreeningNumber of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays96.6 percentage of participants
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.

Time frame: 1 year

Population: Number of participants in the Active Screening arm who had completed the 3-swab protocol.

ArmMeasureValue (NUMBER)
Active ScreeningNumber of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay62 participants
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.

Time frame: 2 years

Population: We reviewed the data on the 69 subjects who were enrolled in the intervention arm of the trial who were cleared of colonization based on the study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active ScreeningRate of Recolonization or Documented Infection With MRSA8 Participants
Secondary

Sensitivity of First PCR Assay

Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.

Time frame: 1 year

ArmMeasureValue (NUMBER)
Active ScreeningSensitivity of First PCR Assay93.9 percentage of true positives
Secondary

Specificity of First PCR Assay.

Specificity of the first PCR assay for subjects enrolled in active arm of trial.

Time frame: 1 year

ArmMeasureValue (NUMBER)
Active ScreeningSpecificity of First PCR Assay.92.0 percentage of true negatives

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026