Organ Transplant Infection Prevention and Detection Project
|ClinicalTrials.gov Identifier: NCT00177801|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 16, 2012
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 or disease||Phase|
|Transplantation Infection||Phase 4|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Organ Transplant Infection Prevention and Detection Project 1.0; Cohort Study of Transplant Recipients at "Ultra-High" Risk for Invasive Fungal Infections|
|Study Start Date :||May 2006|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177801
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||David L Paterson, MD||University of Pitttsburgh|