NCT03933878

Rapid Detection of Airway Pathogens for Lung Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2019-05-01
• Last updated: 2021-03-18

Locations

1 site across 1 country: United States