- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03933878
Recruitment Status Enrolling by invitation
First Posted May 1, 2019
Last update posted May 6, 2020
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
- 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.
United States, California
University of California, San Francisco
BioFire Diagnostics, LLC
Principal Investigator: John Greenland, MD, PhD University of California, San Francisco