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

Methicillin Resistant Staphylococcus Aureus Clinical Trial

— DERAIL_MRSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302210
• Other study ID #: AHRQ 1R18HSO19968-01
• Status: Completed
• Start date: October 2010
• Est. completion date: November 2014

Study information

• Verified date: September 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22302
• Est. completion date: November 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Methicillin Resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem Research Institute	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (75)

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Hacek DM, Robb WJ, Paule SM, Kudrna JC, Stamos VP, Peterson LR. Staphylococcus aureus nasal decolonization in joint replacement surgery reduces infection. Clin Orthop Relat Res. 2008 Jun;466(6):1349-55. doi: 10.1007/s11999-008-0210-y. Epub 2008 Mar 18. — View Citation

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* Note: There are 75 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm	12 months and 24 months
Secondary	To further develop an Infection Control Outreach Program designed to provide expert guidance on infectious disease prevention specific to LTCF's	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.	2 years

External Links

•   HHS Action Plan to Prevent Healthcare-Associated Infections. Health and Human Services. 2009. Last accessed March 13,2010
•   Last assessed March 21, 2010
•   McCaughey B. To catch a deadly germ. New York Times 11/14/2006
•   World Health Organization. The Stop TB strategy. WHO 2006. Last accessed March 13,2010