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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Rapid Detection of Airway Pathogens for Lung Transplantation

Clinicaltrials.gov identifier NCT03933878

Recruitment Status Enrolling by invitation

First Posted May 1, 2019

Last update posted May 6, 2020

Study Description

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.

  • Condition or Disease:Lung Transplantation
    Respiratory Tract Infections
    Pulmonary Infection
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 200 participants
  • Observational Model: Case-Only
  • Time Perspective: Other
  • Official Title: Rapid Detection of Airway Pathogens for Lung Transplantation
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. Time to result [ Time Frame: One year ]
    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.
  • Secondary Outcome Measures: 1. Changes in clinical management or treatment [ Time Frame: One year ]
    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.
  • 2. Agreement between assays [ Time Frame: One year ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: This study will involve adult lung transplant donors and recipients at UCSF.
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.

Contacts and Locations
Contacts
Locations

United States, California
UCSF Parnassus
San Francisco

Sponsors and Collaborators

University of California, San Francisco

BioFire Diagnostics, LLC

Investigators

Principal Investigator: John Greenland, MD, PhD University of California, San Francisco

More Information
  • Responsible Party: University of California, San Francisco
  • ClinicalTrials.gov Identifier: NCT03933878 History of Changes
  • Other Study ID Numbers: P0535801
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 6, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Infection
    Communicable Diseases
    Respiratory Tract Infections