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
  Purpose

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
Infection
Candida
Non Albicans Species

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 80
Study Start Date: August 2006
Estimated Study Completion Date: December 2015
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

candida blood culture

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366223

Locations
United States, Pennsylvania
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
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00366223     History of Changes
Other Study ID Numbers: IRB#0607092
Study First Received: August 18, 2006
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
infection
candida

Additional relevant MeSH terms:
Candidiasis
Mycoses

ClinicalTrials.gov processed this record on April 23, 2014