Changing Patterns of Candida Infections in Urban Medical Centers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00366223
First received: August 18, 2006
Last updated: August 23, 2012
Last verified: August 2012

August 18, 2006
August 23, 2012
August 2006
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Complete list of historical versions of study NCT00366223 on ClinicalTrials.gov Archive Site
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Changing Patterns of Candida Infections in Urban Medical Centers
Changing Patterns of Candida Infections in Urban Medical Centers: Emphasis on the Emergence of Non-albicans Species and Their Influence on Clinical Outcomes

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

Non-Probability Sample

candida blood culture

  • Infection
  • Candida
  • Non Albicans Species
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2015
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Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00366223
IRB#0607092
Yes
University of Pittsburgh
University of Pittsburgh
Pfizer
Principal Investigator: David L Paterson, MD University of Pittsburgh
University of Pittsburgh
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP