Prospective Evaluations of Infectious Complication in Lun... | NCT00177918

Studies
Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

NCT00177918

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 12, 2026Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Disorder Related to Lung Transplantation
Bronchiolitis Obliterans

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006Actual

Primary Completion Date

Jan 1, 2026Actual

Completion Date

Jan 1, 2026Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2026

Last Update Posted Date

Jan 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Label	Type	Description	Intervention Names
lung transplant patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
long term outcome after lung transplantation	looking at death rate five years post lung transplantation	five year follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all lung transplant patients transplanted at UPMC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
EJ Kwak, MD	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D001989	Bronchiolitis Obliterans

Ancestor Terms

ID	Term
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.