Organ Transplant Infection Prevention and Detection Project
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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.
| Study Type: | Observational |
| Study Design: | Time Perspective: 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.
| Enrollment: | 200 |
| Study Start Date: | May 2006 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
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:
- will to sign consent
- speak English
- On lung transplant list awaiting lung transplantation
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | David L Paterson, MD | University of Pitttsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177801 History of Changes |
| Other Study ID Numbers: | IRB# 0408132, CDC |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013