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Methicillin Resistant Staphylococcus AureusDERAIL_MRSANCT01302210

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

An observational study of Methicillin Resistant Staphylococcus Aureus, run by Endeavor Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decolonization
How many people
22,302 participants
Where
1 siteUnited States
Study dates
Oct 2010to Nov 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients that choose not to be included in the program

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NorthShore University HealthSystem Research Institute

    Evanston, Illinois, 60201

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Decolonization
Keywords
MRSA, Cluster Randomized Trial, Infection Control Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecolonizationDrug

    Also called Mupirocin

    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

Study groups in NCT01302210
Study groupRoleWhat they receive
InterventionActive surveillance testing for MRSA and decolonization of positive subjects
Receives: Drug: Decolonization
controlUsual standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm

    Measured: 12 months and 24 months

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2013
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
22,302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302210
Sponsor's protocol ID
AHRQ 1R18HSO19968-01
Acronym
DERAIL_MRSA
Status last verified
Sep 2019
First submitted
23 Feb 2011
Last updated
11 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Capitano B, Leshem OA, Nightingale CH, Nicolau DP. Cost effect of managing methicillin-resistant Staphylococcus aureus in a long-term care facility. J Am Geriatr Soc. 2003 Jan;51(1):10-6. doi: 10.1034/j.1601-5215.2002.51003.x.

    PubMed 12534839

  • Kauffman CA, Terpenning MS, He X, Zarins LT, Ramsey MA, Jorgensen KA, Sottile WS, Bradley SF. Attempts to eradicate methicillin-resistant Staphylococcus aureus from a long-term-care facility with the use of mupirocin ointment. Am J Med. 1993 Apr;94(4):371-8. doi: 10.1016/0002-9343(93)90147-h.

    PubMed 8475930

  • Vriens M, Blok H, Fluit A, Troelstra A, Van Der Werken C, Verhoef J. Costs associated with a strict policy to eradicate methicillin-resistant Staphylococcus aureus in a Dutch University Medical Center: a 10-year survey. Eur J Clin Microbiol Infect Dis. 2002 Nov;21(11):782-6. doi: 10.1007/s10096-002-0811-4. Epub 2002 Nov 8.

    PubMed 12461587

  • Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; SHEA; APIC. SHEA/APIC guideline: infection prevention and control in the long-term care facility, July 2008. Infect Control Hosp Epidemiol. 2008 Sep;29(9):785-814. doi: 10.1086/592416. No abstract available.

    PubMed 18767983

  • Siegel JD, Rhinehart E, Jackson M, Chiarello L; Health Care Infection Control Practices Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health Care Settings. Am J Infect Control. 2007 Dec;35(10 Suppl 2):S65-164. doi: 10.1016/j.ajic.2007.10.007. No abstract available.

    PubMed 18068815

  • Haley RW, Culver DH, White JW, Morgan WM, Emori TG. The nationwide nosocomial infection rate. A new need for vital statistics. Am J Epidemiol. 1985 Feb;121(2):159-67. doi: 10.1093/oxfordjournals.aje.a113988.

    PubMed 4014113

  • Strausbaugh LJ, Joseph CL. The burden of infection in long-term care. Infect Control Hosp Epidemiol. 2000 Oct;21(10):674-9. doi: 10.1086/501712.

    PubMed 11083186

  • Haley RW, Culver DH, White JW, Morgan WM, Emori TG, Munn VP, Hooton TM. The efficacy of infection surveillance and control programs in preventing nosocomial infections in US hospitals. Am J Epidemiol. 1985 Feb;121(2):182-205. doi: 10.1093/oxfordjournals.aje.a113990.

    PubMed 4014115

  • John JF Jr, Ribner BS. Antibiotic resistance in long-term care facilities. Infect Control Hosp Epidemiol. 1991 Apr;12(4):245-50. doi: 10.1086/646332. No abstract available.

    PubMed 1905739

  • Muder RR, Brennen C, Wagener MM, Vickers RM, Rihs JD, Hancock GA, Yee YC, Miller JM, Yu VL. Methicillin-resistant staphylococcal colonization and infection in a long-term care facility. Ann Intern Med. 1991 Jan 15;114(2):107-12. doi: 10.7326/0003-4819-114-2-1-107.

    PubMed 1984384

  • Bradley SF, Terpenning MS, Ramsey MA, Zarins LT, Jorgensen KA, Sottile WS, Schaberg DR, Kauffman CA. Methicillin-resistant Staphylococcus aureus: colonization and infection in a long-term care facility. Ann Intern Med. 1991 Sep 15;115(6):417-22. doi: 10.7326/0003-4819-115-6-417.

    PubMed 1908198

  • Strausbaugh LJ, Jacobson C, Sewell DL, Potter S, Ward TT. Methicillin-resistant Staphylococcus aureus in extended-care facilities: experiences in a Veterans' Affairs nursing home and a review of the literature. Infect Control Hosp Epidemiol. 1991 Jan;12(1):36-45. doi: 10.1086/646236.

    PubMed 1999642

  • Boyce JM. Methicillin-resistant Staphylococcus aureus in hospitals and long-term care facilities: microbiology, epidemiology, and preventive measures. Infect Control Hosp Epidemiol. 1992 Dec;13(12):725-37. doi: 10.1086/648346. No abstract available.

    PubMed 1289400

  • Trick WE, Weinstein RA, DeMarais PL, Kuehnert MJ, Tomaska W, Nathan C, Rice TW, McAllister SK, Carson LA, Jarvis WR. Colonization of skilled-care facility residents with antimicrobial-resistant pathogens. J Am Geriatr Soc. 2001 Mar;49(3):270-6. doi: 10.1046/j.1532-5415.2001.4930270.x.

    PubMed 11300237

  • Stone ND, Lewis DR, Lowery HK, Darrow LA, Kroll CM, Gaynes RP, Jernigan JA, McGowan JE Jr, Tenover FC, Richards CL Jr. Importance of bacterial burden among methicillin-resistant Staphylococcus aureus carriers in a long-term care facility. Infect Control Hosp Epidemiol. 2008 Feb;29(2):143-8. doi: 10.1086/526437.

    PubMed 18179369

Questions about this trial

What is this clinical trial studying?

An observational study of Methicillin Resistant Staphylococcus Aureus, run by Endeavor Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302210, which also lists 75 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.

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