NCT01234831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 30, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 31, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

October 28, 2010

Results QC Date

October 2, 2012

Last Update Submit

September 29, 2017

Conditions

MRSA Colonization

Keywords

MRSAcolonizationnucleic acid amplificationchromogenic agar

Outcome Measures

Primary Outcomes (3)

  • 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

  • Completion of Screening Protocol in Both Trial Arms

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

    1 year

  • 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 Outcomes (4)

  • Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay

    1 year

  • Sensitivity of First PCR Assay

    1 year

  • Specificity of First PCR Assay.

    1 year

  • Rate of Recolonization or Documented Infection With MRSA

    2 years

Study Arms (2)

Active Screening

OTHER

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

Passive Screening

OTHER

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

Interventions

nucleic acid amplification of nasal swab; nasal swab cultureDEVICE

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.

Also known as: Cepheid Xpert MRSA, BD CHROMagar
Active Screening
Nasal swab cultureOTHER

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.

Also known as: BD CHROMagar
Passive Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • last positive MRSA culture greater than 3 months old
  • admitted to hospital

You may not qualify if:

  • age \< 18
  • last positive MRSA culture less than or equal to 3 months old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 24452168DERIVED

  • 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.

    PMID: 23572482DERIVED

Related Links

Limitations and Caveats

This study was conducted at a single tertiary academic center and in the absence of any national guidelines, we implemented the local standard of care for discontinuation of CP, the components of which are found in variable combinations nationally.

Results Point of Contact

Title
Dr. Erica S. Shenoy
Organization
Massachusetts General Hospital
eshenoy@partners.org
617-726-2036

Study Officials

  • David C Hooper, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Erica S Shenoy, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Chief, Infection Control Unit

Study Record Dates

First Submitted

October 28, 2010

First Posted

November 4, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2016

Last Updated

October 31, 2017

Results First Posted

November 30, 2012

Record last verified: 2017-09

Locations

US(1)