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Trial record 93 of 3477 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT01302210
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
NorthShore University HealthSystem

Brief Summary:
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 or disease Intervention/treatment
Methicillin Resistant Staphylococcus Aureus Drug: Decolonization

Detailed Description:
The primary endpoint will be measuring the reduction in MRSA colonization prevalence (percentage rate) in the intervention arm as compared to the control arm. One secondary endpoint is to compare the rate of MRSA disease (number of infections per 1,000 patients and 10,000 patient days) 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 resolve these problems and the other that a partnership between acute and long-term care (e.g., ongoing relationship spanning at least 5 years) is beneficial in dealing with patient safety and quality practices across the United Sates Healthcare continuum.

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Study Type : Observational
Actual Enrollment : 22302 participants
Official Title: Detection, Education, Research and Decolonization Without Isolation in Long-term Care to Control(DERAIL)MRSA
Study Start Date : October 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Group/Cohort Intervention/treatment
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

control
Usual standard of care



Primary Outcome Measures :
  1. To record 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 ]
    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 :
  1. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302210


Locations
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United States, Illinois
NorthShore University HealthSystem Research Institute
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Lance R Peterson, MD NorthShore University HealthSystem

Additional Information:
Publications of Results:
Other Publications:
O'Dowd A. NHS may miss target on reducing MRSA by 2008, minister says. BMJ 2006;333(7575:938
Peterson LR, Hacek DM, Beaumont JL, Boehm S, Gonzolzaes T-M, Gocht N, Robicsek A. Impact of a 4-Year Universal Surveillance and Decolonization Program to Control Methicillin-Resistant Staphylococcus aureus (MRSA). In Program and Abstracts, Fifth Decennial International Conference on Healthcare-Associated Infection. Atlanta, GA. March 18-22, 2010
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.

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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01302210     History of Changes
Other Study ID Numbers: AHRQ 1R18HSO19968-01
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NorthShore University HealthSystem:
MRSA
Cluster Randomized Trial
Infection Control Intervention
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action