- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00177918
Prospective Evaluations of Infectious Complication in Lung Transplant Recipients
May 8, 2023 updated by: EJ Kwak, University of Pittsburgh
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kailey Hughes Kramer, MPH
- Phone Number: 412-648-6453
- Email: hugheskl4@upmc.edu
Study Contact Backup
- Name: EJ Kwak, MD
- Phone Number: 412-648-6401
- Email: kwakej@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh Medical Center
-
Contact:
- Kailey Hughes Kramer, MPH
- Phone Number: 412-648-6453
- Email: hugheskl4@upmc.edu
-
Contact:
- EJ Kwak, MD
- Phone Number: 412-648-6489
- Email: kwakej@upmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
all lung transplant patients transplanted at UPMC
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
lung transplant patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
long term outcome after lung transplantation
Time Frame: five year follow up
|
looking at death rate five years post lung transplantation
|
five year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: EJ Kwak, MD, University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 0212095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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