Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

This study is currently recruiting participants.
Verified July 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177918
First received: September 13, 2005
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition
Disorder Related to Lung Transplantation
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluations of Infectious Complications in Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • long term outcome after lung transplantation [ Time Frame: five year follow up ] [ Designated as safety issue: No ]
    looking at death rate five years post lung transplantation


Biospecimen Retention:   Samples Without DNA

All biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers will be removed 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. All samples that are provided to outside facilities will be sent with a code number. Samples may be sent to other investigators not associated with this study to perform diagnostic testing (e.g., viral, fungal, bacterial and immunological). All samples will be provided to investigators not associated with the study without any identifiers and only contain a code number. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed.


Estimated Enrollment: 600
Study Start Date: August 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung transplant patients

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.

  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

all lung transplant patients transplanted at UPMC

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177918

Contacts
Contact: EJ Kwak, MD 412-648-6401 kwakej@upmc.edu
Contact: Diana Pakstis, RN, BSN 412-648-6401 pakstisdl@dom.pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: EJ Kwak, MD    412-648-6489    kwakej@upmc.edu   
Contact: Diana Pakstis, RN, BSN, MBA    412-648-6553    dlp5@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: EJ Kwak, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177918     History of Changes
Other Study ID Numbers: IRB # 0212095
Study First Received: September 13, 2005
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lung Transplant

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 15, 2014