Changing Patterns of Candida Infections in Urban Medical Centers
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pittsburgh
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00366223
First received: August 18, 2006
Last updated: December 16, 2015
Last verified: December 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Primary Outcome Measures:
- dead or alive [ Time Frame: end of study ] [ Designated as safety issue: No ]Health status
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 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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:
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366223
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
| 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: | December 16, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
infection candida |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Candidiasis Mycoses |
ClinicalTrials.gov processed this record on September 23, 2016