Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
John Greenland

Description

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.

Details

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.

Keywords

Lung Transplantation Respiratory Tract Infections Pulmonary Infection Infection Communicable Diseases

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • UCSF Parnassus
    San Francisco California 94143 United States

Lead Scientist

  • John Greenland
    Dr. Greenland is an Assistant Professor of Medicine at UCSF and Staff Physician at the San Francisco VA Medical Center. He received his undergraduate degree from Stanford and completed his PhD through the Harvard graduate program in Virology. He received an MD from the Harvard-MIT Division of Health Science and Technology.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03933878
Study Type
Observational
Last Updated