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Organ Transplant Infection Prevention and Detection Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177801
First received: September 13, 2005
Last updated: August 14, 2012
Last verified: August 2012
  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
Transplantation Infection
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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. 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
Study Population

lung transplant recepients

Criteria

Inclusion Criteria:

  • will to sign consent
  • speak English
  • On lung transplant list awaiting lung transplantation
  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: NCT00177801

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 25, 2014