Clinical trial NCT03933878: Rapid Detection of Airway Pathogens for Lung Transplantation
Official title: Rapid Detection of Airway Pathogens for Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Respiratory Tract Infections
Pulmonary Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: BioFire Diagnostics, LLC
First posted: 2019-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve adult lung transplant donors and recipients at UCSF.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to result
timeFrame: One year
Secondary outcomes:
measure: Changes in clinical management or treatment
timeFrame: One year
measure: Agreement between assays
timeFrame: One year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Parnassus
state: California
Study officials:
affiliation: University of California, San Francisco
name: John Greenland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: