Prospective Evaluations of Infectious Complication in Lung Transplant Recipients
Status: | Recruiting |
---|---|
Conditions: | Bronchitis, Hospital, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/14/2018 |
Start Date: | August 2006 |
End Date: | December 2025 |
Contact: | EJ Kwak, MD |
Email: | kwakej@upmc.edu |
Phone: | 412-648-6401 |
Prospective Evaluations of Infectious Complications in Lung Transplant Recipients
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.
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.
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.
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.
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.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Phone: 412-648-6489
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