- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01302210
Oppdagelse, utdanning, forskning og avkolonisering uten isolasjon i langtidspleieinstitusjoner (DERAIL_MRSA)
9. september 2019 oppdatert av: NorthShore University HealthSystem
Deteksjon, utdanning, forskning og avkolonisering uten isolasjon i langtidspleie for å kontrollere(DERAIL)MRSA
Vår hypotese for DERAIL MRSA-programmet er at man trygt kan fjerne koloniseringsrisikoen fra nesten alle beboere (pasienter) på en måte som ikke forstyrrer ønsket livsstil for personer i disse fasilitetene og derved redusere risikoen for infeksjon og senke kostnadene for omsorg ved å unngå sykdom som kan forebygges.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Det primære endepunktet vil være å måle reduksjonen i MRSA-koloniseringsprevalens (prosentsats) i intervensjonsarmen sammenlignet med kontrollarmen.
Et sekundært endepunkt er å sammenligne frekvensen av MRSA-sykdom (antall infeksjoner per 1 000 pasienter og 10 000 pasientdager) i intervensjons- og kontrollarmene.
Det andre sekundære endepunktet er å bestemme kostnadene for MRSA-screening og dekolonisering og sammenligne den med kostnadene ved MRSA-sykdomsbehandling (både medisinkostnader og utgifter til eventuell nødvendig sykehusinnleggelse for behandling av MRSA-infeksjonsterapi) i kontrollarmen.
Å oppnå vårt primære mål med MRSA-kontroll vil også demonstrere to sekundære mål som etterforskerne tar sikte på å oppnå: det ene er at en vitenskapelig, planlagt tilnærming til spørsmålet om spesifikke helsevesen-assosierte infeksjoner i LTCF-er kan løse disse problemene og det andre at et partnerskap mellom akutte og langtidspleie (f.eks. pågående forhold som strekker seg over minst 5 år) er fordelaktig når det gjelder å håndtere pasientsikkerhet og kvalitetspraksis på tvers av United Sates Healthcare kontinuum.
Studietype
Observasjonsmessig
Registrering (Faktiske)
22302
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Illinois
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Evanston, Illinois, Forente stater, 60201
- NorthShore University HealthSystem Research Institute
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Alle pasienter i 18 LTCF-sykepleieenheter er tilfeldig valgt som intervensjons- eller kontrollenheter
Ekskluderingskriterier:
- Pasienter som velger å ikke bli inkludert i programmet
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Innblanding
Aktiv overvåkingstesting for MRSA og dekolonisering av positive individer
|
5 dagers kur med mupirocin kalsium 2 % to ganger daglig til nesen og ethvert åpent sår pluss badekar eller dusj med 4 % klorheksidin brukt som flytende såpe
Andre navn:
|
kontroll
Vanlig omsorgsstandard
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
For å registrere effektiviteten av en innleggelsestesting og umiddelbar avkolonisering av positive personers protokoll for å redusere MRSA-koloniseringsprevalens i langtidspleieinstitusjoner (LTCF-er)
Tidsramme: 12 måneder og 24 måneder
|
Infeksjonskontroll klynge randomisert studie: måling av reduksjonen i MRSA koloniseringsprevalens (rate) i intervensjonsarmen sammenlignet med kontrollarmen
|
12 måneder og 24 måneder
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Å videreutvikle et infeksjonskontrolloppsøkende program designet for å gi ekspertveiledning om forebygging av infeksjonssykdommer spesifikke for LTCF-er
Tidsramme: 2 år
|
Sammenlign frekvensen av MRSA-sykdom i intervensjons- og kontrollarmer.
Bestem kostnadene for MRSA-screening og dekolonisering og sammenlign den med kostnadene ved MRSA-sykdomsbehandling (både medisinkostnadene og utgiftene til eventuell nødvendig sykehusinnleggelse for behandling av MRSA-infeksjonsbehandling) i kontrollarmen.
|
2 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- 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
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- 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.
- Peterson LR, Boehm S, Beaumont JL, Patel PA, Schora DM, Peterson KE, Burdsall D, Hines C, Fausone M, Robicsek A, Smith BA. Reduction of methicillin-resistant Staphylococcus aureus infection in long-term care is possible while maintaining patient socialization: A prospective randomized clinical trial. Am J Infect Control. 2016 Dec 1;44(12):1622-1627. doi: 10.1016/j.ajic.2016.04.251. Epub 2016 Aug 1.
- Schora DM, Boehm S, Das S, Patel PA, O'Brien J, Hines C, Burdsall D, Beaumont J, Peterson K, Fausone M, Peterson LR. Impact of Detection, Education, Research and Decolonization without Isolation in Long-term care (DERAIL) on methicillin-resistant Staphylococcus aureus colonization and transmission at 3 long-term care facilities. Am J Infect Control. 2014 Oct;42(10 Suppl):S269-73. doi: 10.1016/j.ajic.2014.05.011.
- Das S, Anderson CJ, Grayes A, Mendoza K, Harazin M, Schora DM, Peterson LR. Nasal Carriage of Epidemic Methicillin-Resistant Staphylococcus aureus 15 (EMRSA-15) Clone Observed in Three Chicago-Area Long-Term Care Facilities. Antimicrob Agents Chemother. 2013 Sep;57(9):4551-4553. doi: 10.1128/AAC.00528-13. Epub 2013 Jun 24.
Hjelpsomme linker
- Last assessed March 21, 2010
- HHS Action Plan to Prevent Healthcare-Associated Infections. Health and Human Services. 2009. Last accessed March 13,2010
- World Health Organization. The Stop TB strategy. WHO 2006. Last accessed March 13,2010
- McCaughey B. To catch a deadly germ. New York Times 11/14/2006
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
23. februar 2011
Først innsendt som oppfylte QC-kriteriene
23. februar 2011
Først lagt ut (Anslag)
24. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AHRQ 1R18HSO19968-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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