Rapid Detection of Airway Pathogens for Lung Transplantation

Respiratory Tract Infections Clinical Trial

Official title:

Rapid Detection of Airway Pathogens for Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933878
• Other study ID #: P0535801
• Status: Completed
• Start date: March 19, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: March 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lung Transplantation
• Pulmonary Infection
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	UCSF Parnassus	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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