Clincosm LogoSign in Get a demo

Changing Patterns of Candida Infections in Urban Medical Centers

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00366223
Collaborator
Pfizer (Industry)
80
Enrollment
1
Location
130
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the changing patterns of infection caused by Candida species in urban medical centers and its influence on patient outcomes. A retrospective cohort study design will be employed with the main outcome measure being hospital mortality. Secondary outcomes including microbiologic clearance of the infection, duration of hospitalization, and the intensive care unit (ICU) length of stay will also be assessed.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The following information that was collected as part of the patient's clinical treatment will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Changing Patterns of Candida Infections in Urban Medical Centers: Emphasis on the Emergence of Non-albicans Species and Their Influence on Clinical Outcomes
    Actual Study Start Date :
    Aug 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. dead or alive [end of study]

      Health status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All hospitalized patients with a positive blood culture for Candida will be eligible.
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • Pfizer

    Investigators

    • Principal Investigator: David L Paterson, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT00366223
    Other Study ID Numbers:
    • IRB#0607092
    First Posted:
    Aug 21, 2006
    Last Update Posted:
    Jun 12, 2018
    Last Verified:
    Jun 1, 2018
    Keywords provided by University of Pittsburgh
    infection
    candida
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Candidiasis

    Study Results

    No Results Posted as of Jun 12, 2018