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| Sponsors and Collaborators: |
University of Pittsburgh Centers for Disease Control and Prevention |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177801 |
Purpose
Fungal infections are leading causes of morbidity and mortality in transplant recipients, yet comprehensive epidemiologic studies in this area are lacking. For this reason, the Centers for Disease Control and Prevention have provided a grant to the University of Pittsburgh to study this subject.
The study has four specific aims:
1. To determine the risk of fungal infections in a center where "tolerogenic" immunosuppressive protocols are currently in place, and to determine whether there are any measures of immune system function which correlate with risk of fungal infection.
2: To create a repository of serum, urine and bronchoalveolar lavage specimens for the purpose of determining the effectiveness of novel diagnostic tests for invasive fungal infections. Such a repository could also be utilized for the purpose of determining the effectiveness of novel diagnostic tests for viral infections such as West Nile Virus, cytomegalovirus, HHV-6 and HHV-8.
Specific aim 1 will be investigated by creating a prospective database of solid organ transplant recipients at the University of Pittsburgh Medical Center, including demographic factors as well as subsequent development of infection. The immune function of patients will be assessed by measuring T cell subsets and assessing T cell function using the Cylex assay. Specific aim 2 involves collection of serum, urine and bronchoalveolar lavage fluid. These specimens will be stored and later tested at the Centers for Disease Control and Prevention in the assessment of novel tests developed for the diagnosis of invasive fungal infections.
| Condition | Phase |
|
Post Lung Transplantation |
Phase IV |
| MedlinePlus related topics: | Fungal Infections Lung Transplantation Molds |
| Study Type: | Observational |
| Study Design: | Other, Prospective |
| Official Title: | Organ Transplant Infection Prevention and Detection Project 1.0; Cohort Study of Transplant Recipients at "Ultra-High" Risk for Invasive Fungal Infections |
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. The biologic samples may be given to the Centers for Disease Control and Prevention. 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: | 3000 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2012 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
lung transplant recepients
Inclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |||||
| University of Pittsburgh Medical Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: David L Paterson, MD 412-648-6401 patersond@dom.pitt.edu | |||||
| Contact: Mary Ellen Carey, RN, BSN 412-648-6453 cheswickm@dom.pitt.edu | |||||
| Principal Investigator: David Paterson, MD | |||||
| University of Pittsburgh Medical Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: David L Paterson, MD 412-648-6401 Patersond@dom.pitt.edu | |||||
| Contact: Mary Ellen Carey, RN, BSN 412-648-6453 cheswickm@dom.pitt.edu | |||||
| Principal Investigator: David L Paterson, MD | |||||
| University of Pittsburgh |
| Centers for Disease Control and Prevention |
| Principal Investigator: | David L Paterson, MD | University of Pitttsburgh |
More Information
| Responsible Party: | UPMC ( David Paterson, MD ) |
| Study ID Numbers: | IRB# 0408132, CDC |
| First Received: | September 13, 2005 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00177801 |
| Health Authority: | United States: Institutional Review Board |
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