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Detection, Education, Research and Decolonization Without Isolation in Long-term Care Facilities (DERAIL MRSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01302210
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization risk from nearly all residents (patients) in a way that does not interfere with the desired life-style for persons in these facilities and thereby reduce the risk of infection and lower the cost of care by avoiding preventable disease.


Condition Intervention Phase
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
 Drug: Decolonization
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Detection, Education, Research and Decolonization Without Isolation in Long-term Care to Control(DERAIL)MRSA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • To test the effectiveness of an admission testing and immediate decolonization of positive persons protocol for reducing MRSA colonization prevalence in long term care facilities (LTCF's) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
    Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm


Secondary Outcome Measures:
  • To further develop an Infection Control Outreach Program designed to provide expert guidance on infectious disease prevention specific to LTCF's [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Compare the rate of MRSA disease in the intervention and control arms. Determine the cost of MRSA screening and decolonization and compare it to the cost of MRSA disease treatment (both medication cost and the expense of any needed hospitalization for therapy of MRSA infection therapy) in the control arm.


Estimated Enrollment: 4200
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Active surveillance testing for MRSA and decolonization of positive subjects
 Drug: Decolonization
5 day regimen of mupirocin calcium 2% twice daily to the nares and any open wound plus bath or shower with 4% chlorhexidine used as a liquid soap
Other Name: Mupirocin
No Intervention: control
Usual standard of care

Detailed Description:

The primary endpoint will be measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm. One secondary endpoint is to compare the rate of MRSA disease in the intervention and control arms. The other secondary endpoint is to determine the cost of MRSA screening and decolonization and compare it to the cost of MRSA disease treatment (both medication cost and the expense of any needed hospitalization for therapy of MRSA infection therapy) in the control arm. Achieving our primary goal of MRSA control will also demonstrate two secondary goals wthe investigators aim to achieve: one being that a scientific, planned approach to the issue of specific healthcare-associated infection in LTCFs can solve these problems and the other that a partnership between acute and long-term care is beneficial in dealing with patient safety and quality practices across the United Sates Healthcare continuum.

  Eligibility

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

Inclusion Criteria:

  • All patients in 18 LTCF nursing units randomly selected as intervention or control units

Exclusion Criteria:

  • Patients that choose not to be included in the program
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302210

Locations
United States, Illinois
NorthShore University HealthSystem Research Institute
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
Principal Investigator: Lance R Peterson, MD NorthShore University HealthSystem
  More Information

Additional Information:
HHS Action Plan to Prevent Healthcare-Associated Infections. Health and Human Services. 2009. Last accessed March 13,2010  This link exits the ClinicalTrials.gov site
World Health Organization. The Stop TB strategy. WHO 2006. Last accessed March 13,2010  This link exits the ClinicalTrials.gov site
McCaughey B. To catch a deadly germ. New York Times 11/14/2006  This link exits the ClinicalTrials.gov site
Scott RD. The direct Medical costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. CDC. Last accessed March 20, 2010.  This link exits the ClinicalTrials.gov site
AHRQ. Cluster randomized trial of hospitals to assess impact of targeted versus universal strategies to reduce methicillin-resistant Staphylococcus aureus (MRSA) in Intensive Care Units. Last assessed March 21,2010.  This link exits the ClinicalTrials.gov site
Centers for disease Control and Prevention. Campaign to Prevent Antimicrobial Resistance in Healthcare Settings. Last assessed March 22, 2010.  This link exits the ClinicalTrials.gov site

Publications:
O'Dowd A. NHS may miss target on reducing MRSA by 2008, minister says. BMJ 2006;333(7575:938
Robicsek A, Paule SM, Hacek DM, Gonzalzles TM, Thomson RB, Peterson LR. How long after colonization does MRSA disease occur? IN: Program and Abstracts, Forty-eighth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washinton, D.C., October 25-28, 2008. Abstract K-1708.
Robicsek A, Hacek DM, Fisher A, Peterson LR. Progression to MRSA infection in asymptomatic carriers (AC) detected through a hospital-based universal surveillance and decolonization program. IN: Program and Abstracts. Forty-fourth Annual Meeting, Infectious Diseases Society of America, Toronto, Canada, October 12-15, 2006. Abstract 390.
Hacek D, Paule S, Small M, Gottschall R, Thomson R, Peterson L. Comparison of colisitin naladixic agar (CNA), mannitol salt agar (MS) and phenol mannitol broth with antibiotics (PMB) for the recovery of Staphylococcus aureus (SA) from nasal swabs. Abstracts of the One-hundreth and third Annual Meeting of the American Society for Microbiology,Washinto, DC. May 18-22,2003. Abstract C-323.
Paule S, Robicsek A, Suseno M, Kaul KL, Peterson LR. Incidence of mupirocin resistance in methicillin-resistant Staphylococcus aureus (MRSA) during universal surveillance and decolonization. IN: Program and Abstracts, Forty-sixth Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27-30,2006. Abstract C2-1149.

Responsible Party: Lance R Peterson, M.D, NorthShore University HealthSystem Dept of Pathology/Lab Medicine
ClinicalTrials.gov Identifier: NCT01302210     History of Changes
Other Study ID Numbers: AHRQ 1R18HSO19968-01
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
MRSA
Cluster Randomized Trial
Infection Control Intervention

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mupirocin
Protein Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013