Changing Patterns of Candida Infections in Urban Medical Centers

NCT00366223

Last updated date
Study Location
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection, Candida, Non Albicans Species
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- None

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Infection, Candida, Non Albicans SpeciesChanging Patterns of Candida Infections in Urban Medical Centers
NCT00366223
  1. Pittsburgh, Pennsylvania
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Changing Patterns of Candida Infections in Urban Medical Centers
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
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population candida blood culture
Condition
  • Infection
  • Candida
  • Non Albicans Species
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2006)
80
Original Enrollment Same as current
Actual Study Completion Date June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00366223
Other Study ID Numbers IRB#0607092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Pfizer
Investigators
Principal Investigator:David L Paterson, MDUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2018