Skip to main content
Clinical Trials/NCT00177918
NCT00177918
Completed
Not Applicable

Prospective Evaluations of Infectious Complications in Lung Transplant Recipients

University of Pittsburgh1 site in 1 country600 target enrollmentAugust 1, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorder Related to Lung Transplantation
Sponsor
University of Pittsburgh
Enrollment
600
Locations
1
Primary Endpoint
long term outcome after lung transplantation
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The primary aim of this study is to determine prospectively the viral and C. pneumoniae infection prevalence and outcomes of infections in lung transplant recipients. The study will also determine the correlation of C. pneumoniae infection with the development of obliterans in lung transplant recipients.

Detailed Description

This is a prospective cohort study of lung transplant recipients and those who will undergo lung transplantation. Patients will be identified by the pulmonologist performing the bronchoscopy. The patient's sera (obtained from a one time blood draw of 10 milliliters - two tablespoons) and cell pellet of BAL will be frozen at -70º C. Once the active or non- OB status is determined by the pathologist, stored BAL fluid (cell pellet) will be analyzed. C.pneumoniae serum titers will also be measured and compared with stored pre-transplant sera. Left over cell pellet of the BAL fluid will be used to measure the presence of C. pneumoniae by PCR method. Additionally PCR will be performed for other viruses (CMV, EBV, HHV6 \& 7, human metapneumo virus and human rhino virus). In addition, during the bronchoscopy procedure as part of the patient's standard of care, a biopsy is obtained. This is done during the bronchoscopy procedure. The tissue is then sent to the pathology lab. We will collect residual (excess) tissue samples to perform research related testing. This testing will determine if we can predict other types of infections and early onset of rejection. These determinations will assist clinicians in administering appropriate dosage levels of antibiotics required to prevent or treat infections and help stop the rejection process. The subject will be asked a few questions about pulmonary symptoms that will not take more than five minutes by one of the investigators or study coordinator. The subject's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard to post transplant care), medication information, as well as any testing/procedures during the transplant follow-up period. This information and results of the tests/procedures will become part of the research record.

Registry
clinicaltrials.gov
Start Date
August 1, 2006
End Date
January 1, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

EJ Kwak

Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Patients who have undergone lung transplantation or will undergo a lung transplant at the University of Pittsburgh Medical Center and are alive following transplant period will be eligible for the study.

Exclusion Criteria

  • Subjects not willing to participate in the research study.

Outcomes

Primary Outcomes

long term outcome after lung transplantation

Time Frame: five year follow up

looking at death rate five years post lung transplantation

Study Sites (1)

Loading locations...

Similar Trials