- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00018434
The Epidemiology of Infection With Vancomycin-Resistant Enterococci
25. juni 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- VA Maryland Health Care System
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Patients from the intensive care units with or without VRE colonization.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Gruppe 1
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 1998
Studieafslutning
1. juni 2001
Datoer for studieregistrering
Først indsendt
3. juli 2001
Først indsendt, der opfyldte QC-kriterier
4. juli 2001
Først opslået (Skøn)
5. juli 2001
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CADE-RCD2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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