Rapid Detection of Airway Pathogens for Lung Transplantation

NCT03933878 | Completed

• 1 other identifier: P0535801
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation; Respiratory Tract Infections; Pulmonary Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in clinical management or treatment

  One year

• Agreement between assays

  One year

Study Arms (2)

Post-transplant recipient BAL samples

No intervention will be administered

Donor BAL samples

No intervention will be administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• BioFire Diagnostics, LLC: collaborator

Study Sites (1)

UCSF Parnassus

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• John Greenland, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: March 19, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)