Rapid Detection of Airway Pathogens for Lung Transplantation

NCT ID: NCT03933878

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2021-03-05

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.

Conditions

Lung Transplantation; Respiratory Tract Infections; Pulmonary Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Post-transplant recipient BAL samples

No intervention will be administered

No interventions assigned to this group

Donor BAL samples

No intervention will be administered

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioFire Diagnostics, LLC

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Greenland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Parnassus

San Francisco, California, United States

Countries

United States

Other Identifiers

P0535801

Identifier Type: -

Identifier Source: org_study_id