- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00018434
The Epidemiology of Infection With Vancomycin-Resistant Enterococci
25. juni 2015 oppdatert av: US Department of Veterans Affairs
Current projects study veteran patients with chronic ulcers and MRSA colonization and infection, patients with imipenem-resistant P. aeruginosa colonization and infection, the relationships between staffing pattern, severity of illness and nosocomial infections in intensive care units and infection control practices for veteran patients with suspected tuberculosis.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Nosocomial infections are often caused by antimicrobial-resistant pathogens such as vancomycin resistant enterococci (VRE) and are a major cause increased morbidity, mortality and cost in hospitalized patients.
Nosocomial bloodstream infections (BSI) add 7 to 21 days to the length of stay and cost institutions $3,061 to $40,000.
The average cost of treating patients with VRE BSI has been estimated as 30% more than vancomycin sensitive enterococcal BSI.
In addition, the attributable mortality of VRE BSI has been estimated as 37%.
Preventing VRE infection and VRE transmission is clearly important and understanding the risk factors for each is a necessary first step.
The goal of this three year study is to identify potentially effective interventions for the prevention of VRE infection and colonization Before testing interventions, we need to identify risk factors for VRE infection which will allow us to (1) identify potentially effective interventions and (2) focus on patients at highest risk for VRE infection.
We will study the effect of antibiotic use, particularly vancomycin, and impaired host defenses on VRE infection in a large cohort study of VRE colonized patients.
The goal is to develop a statistical model, which will allow us to identify alterable risk factors, which could reduce the risk of VRE infection.
Many case-control studies have been performed to study VRE colonization and infection; however, most of these studies were small with insufficient sample sizes for multivariate modeling.
Vancomycin-resistant enterococci (VRE) can be transmitted from patient to patient.
We propose to model the ecological relationship between the rate of VRE transmission and the pre-existing prevalence of VRE in an ICU to determine whether the relationship is linear or exponential.
The objective is to determine at what point the rate of transmission increases significantly that specific interventions should occur (e.g.
reverse isolation of all patients, close unit to new admissions).
Controlling health care costs is an important part of health care today and is particularly important in the capitated reimbursement system that VHA is adopting.
Potential interventions to prevent VRE infections and VRE transmission must be cost-effective to the healthcare system to justify their adoption.
The current study will quantify the operational costs associated with VRE colonization and infection in hospitalized patients compared to their non-colonized counterparts.
Patients from the intensive care units with and without VRE colonization will be covaried for severity of illness and stratified by Major Diagnostic Category (by primary ICD-9 code) and marginal health care costs compared.
This estimate can then be used to examine the potential cost-effectiveness of identified interventions, and to justify the system-wide costs of implementing these interventions.
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- VA Maryland Health Care System
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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 til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Patients from the intensive care units with or without VRE colonization.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Gruppe 1
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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. juli 1998
Studiet fullført
1. juni 2001
Datoer for studieregistrering
Først innsendt
3. juli 2001
Først innsendt som oppfylte QC-kriteriene
4. juli 2001
Først lagt ut (Anslag)
5. juli 2001
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CADE-RCD2
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