Rapid Detection of Airway Pathogens for Lung Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Lung Transplantation; 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Parnassus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will involve adult lung transplant donors and recipients at UCSF.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to result	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in clinical management or treatment	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.	One year
Agreement between assays	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.	One year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: BioFire Diagnostics, LLC
• Investigators: Principal Investigator: John Greenland, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: P0535801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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