Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177918
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2005-09-13
Brief Title:
Prospective Evaluations of Infectious Complication in Lung Transplant Recipients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Prospective Evaluations of Infectious Complications in Lung Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients sera obtained from a one time blood draw of 10 milliliters - two tablespoons and cell pellet of BAL will be frozen at -70ยบ C Once the active or non- OB status is determined by the pathologist stored BAL fluid cell pellet will be analyzed Cpneumoniae 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 patients 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 subjects 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 testingprocedures during the transplant follow-up period This information and results of the testsprocedures will become part of the research record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None