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Rapid Detection of Airway Pathogens for Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933878
Recruitment Status : Enrolling by invitation
First Posted : May 1, 2019
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
BioFire Diagnostics, LLC
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Pneumonias and lower respiratory tract infections can have important long-term consequences, particularly in the context of lung transplantation, where pneumonia is a major cause of death. Candidate organs and lung transplant recipients undergo bronchoscopic inspection to assess for lower respiratory tract infection, but traditional culture methods take time, leading to increased risk from inappropriate therapy. The investigators hypothesize that the rapid detection of lower respiratory tract infection, using a semi-quantitative multiplex molecular assay, can decrease the time to appropriate clinical decision making.

Condition or disease
Lung Transplantation Respiratory Tract Infections Pulmonary Infection

Detailed Description:
Before and after lung transplantation, clinical decision-making for infection diagnosis can be delayed by the time requirements of traditional culture techniques. This study will enroll lung transplant donor candidates and recipients undergoing assessment for lower respiratory tract infection by bronchoscopic alveolar lavage (or washing). The investigators will record bronchoscopy time and time to test result and clinical management decision based on traditional culture methods. The investigators will perform a semi-quantitative multiplex molecular assay for lower respiratory tract infection using the BioFire Pneumonia Panel and these results will be evaluated by clinicians not directly involved in patient care. Timing and outcome of clinical decision making will be recorded. The investigators will compare the time to result using a paired Student's t-test between traditional and molecular methods. Secondary endpoints include time to clinical decision, postulated changes in clinical decisions, and agreement between methods.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Rapid Detection of Airway Pathogens for Lung Transplantation
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Post-transplant recipient BAL samples
No intervention will be administered
Donor BAL samples
No intervention will be administered



Primary Outcome Measures :
  1. Time to result [ Time Frame: One year ]
    The investigators will measure the difference between the time that microbiology results became available using standard of care diagnostics and the time of result from molecular methods.


Secondary Outcome Measures :
  1. Changes in clinical management or treatment [ Time Frame: One year ]
    The investigators will record clinical management decisions resulting from both the BioFire molecular diagnostic assay and the current standard of care clinical procedures. The study will report the percentage agreement on treatment decisions between the two diagnostic pathways.

  2. Agreement between assays [ Time Frame: One year ]
    The investigators will record pathogen detection results from both the BioFire molecular diagnostic assay and the current standard of care clinical procedures. The investigators will then report the percentage agreement on pathogen detection between the two diagnostic pathways.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will involve adult lung transplant donors and recipients at UCSF.
Criteria

Inclusion Criteria:

  • Subjects will be included if subjects are able and willing to provide informed consent for this study as part of an ongoing prospective biorepository and clinical data repository cohort study.
  • Donors can be included as subjects if families provide informed consent.

Exclusion Criteria:

  • Samples from donor organs will be excluded if the organs are unlikely likely to be used based on review of preliminary data.
  • Post-transplant samples will be excluded if the suspicion for infection is sufficiently low that lavage samples are not sent for microbiologic workup or there is insufficient sample for research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933878


Locations
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United States, California
UCSF Parnassus
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
BioFire Diagnostics, LLC
Investigators
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Principal Investigator: John Greenland, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03933878    
Other Study ID Numbers: P0535801
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases