|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Pittsburgh Physicians own funding |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00298077 |
Purpose
The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection
| Condition |
|---|
|
Infection Organ Transplant Recipients |
| Study Type: | Observational |
| Study Design: | Retrospective |
| Official Title: | A Retrospective Review of Infections Usually Observed in Transplant Recipients |
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: | 500 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2016 |
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, previous medical surgical conditions, microbiology and virology culture results, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, pathology and histology results, summaries of admissions, discharges, operations, death, medications, clinical outcome gender, height, weight, ethnicity, date of transplant, type of transplant, primary diagnosis, and past medical history. Also required are medical summaries of admissions, discharges, operations, and deaths
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
transplant recipients with infections
Inclusion Criteria:
Exclusion:
Contacts and Locations| Contact: Eun Kwak, MD | 412-648-6401 | kwakej@upmc.edu |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | pakstisdl@dom.pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Eun Kwak, MD 412-648-6401 kwakej@upmc.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
| Principal Investigator: Eun Kwak, MD | |
| Principal Investigator: | Eun Kwak, MD | University of Pittsburgh |
More Information
| Responsible Party: | UPMC ( E. J. Kwak, MD ) |
| Study ID Numbers: | IRB# 0602053 |
| Study First Received: | February 27, 2006 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00298077 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Infection transplant recipients |
|
Communicable Diseases Infection |
