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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366223
Other study ID # IRB#0607092
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2006
Est. completion date June 2017

Study information

Verified date June 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All hospitalized patients with a positive blood culture for Candida will be eligible.

Exclusion Criteria:

Study Design


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary dead or alive Health status end of study
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