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Drug Resistance Factors In Healthcare-associated Pneumonia (DEFINE)

29. juli 2017 opdateret af: Ishaq Lat, Critical Care Pharmacotherapy Trials Network

A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients

Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit generalizability and lead to over-prescription of broad-spectrum antibacterial agents. This will be a prospective, multicenter epidemiological study to characterize pneumonia epidemiology in critically ill adult patients.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Pneumonia is one of the leading causes of death in the United States and is associated with significant costs to the healthcare system. Recent treatment guidelines describe a new subtype of pneumonia, healthcare-associated pneumonia (HCAP), to identify those patients who present to a hospital from the community and are thought to be at greater risk for developing pneumonia due to multidrug resistant organisms (MDRO).

The HCAP categorization scheme is intended to improve the prescription of initial appropriate empiric antibacterial agents and minimize the morbidity and mortality associated with inappropriate empiric selection.However, one of the chief criticisms of the guideline recommendations is that the criteria used to define HCAP is overly broad, which may result in greater use of broad-spectrum antibiotics.

The prevailing notion is that many patients in the community will be at the lowest risk for experiencing MDR pneumonia and can be treated with a less broad anti-infective regimen. Patients with increasing exposure to the healthcare system will receive initial anti-infective therapy that is more broad in an effort to target MDROs. The investigator group believes that it is not simply exposure to the healthcare system that predicts the incidence of MDR pneumonia (i.e., criteria for HCAP), but rather, the "intensity" of exposure to the healthcare system that is predictive of MDR pneumonia. The aim of this study is to identify risk factors for MDR HCAP pneumonia in critically ill patients. .

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

679

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • Hartford Healthcare
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • University of Florida - Jacksonville Hospital
      • Weston, Florida, Forenede Stater, 33331
        • Cleveland Clinic - Florida
    • Georgia
      • Savannah, Georgia, Forenede Stater, 31401
        • Memorial University Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60037
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Roudebush - Indianapolis Veterans Administration Hospital
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40506
        • University of Kentucky Healthcare - Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02116
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02116
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Detroit Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Beaumont Health System
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • University of Minnesota - Fairview Health Services
    • Missouri
      • Kirksville, Missouri, Forenede Stater, 63501
        • Northeast Regional Medical Center
    • New Hampshire
      • Laconia, New Hampshire, Forenede Stater, 03246
        • Lakes Regional General Healthcare
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Medical Center
    • Ohio
      • Canton, Ohio, Forenede Stater, 44708
        • Mercy Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic - Cleveland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny Health Network
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper St. Francis Healthcare
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, Forenede Stater, 78701
        • Seton Healthcare Family
      • Houston, Texas, Forenede Stater, 77030
        • Memorial Hermann Healthcare System
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University Of Wisconsin Hospital
      • Milwaukee, Wisconsin, Forenede Stater
        • Medical College of Wisconsin/ Froedtert Hospital
  • Saudi Arabien
      • Riyahd, Saudi Arabien, 1515
        • Ministry of of National Guard-Health Affaires

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 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years old
  • ICU admission
  • Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days

Exclusion Criteria:

  • Patient stay in ICU for < 24 hours
  • Patient transfer to the ICU from a hospital floor following prescription for anti-infective therapy in the previous 24 hours of ICU admission
  • Diagnosis of cystic fibrosis or bronchiectasis
  • Fungal pneumonia

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of multidrug resistant pneumonia pathogen
Tidsramme: 30 days
30 days

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of pneumonia subtypes
Tidsramme: 30 days
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Critical Care Pharmacotherapy Trials Network

Samarbejdspartnere

University of Arkansas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. november 2016

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

28. februar 2017

Datoer for studieregistrering

Først indsendt

8. april 2016

Først indsendt, der opfyldte QC-kriterier

12. april 2016

Først opslået (Skøn)

13. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15071001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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