This study aims to use a clinically validated metagenomic next-generation sequencing (mNGS) assay to provide a demonstration of precision medicine for diagnosis of acute infectious disease in hospitalized patients. From June 2016 to June 2017, 200 patients will be enrolled from multiple hospitals in California and outside of California. Patients will be evaluated to determine the impact on the mNGS assay on diagnostic yield, hospital costs and clinical outcomes.
This study aims to use a clinically validated metagenomic next-generation sequencing (mNGS) assay to provide a demonstration of precision medicine for diagnosis of acute infectious disease in hospitalized patients, with the goal of directly impacting clinical care and improving patient mortality. This diagnostic test has been previously validated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, the University of California, San Francisco Clinical Microbiology Laboratory. From June 2016 to June 2017, investigators will prospectively enroll 200 patients from multiple hospitals in California (University of California, San Francisco; University of California, Los Angeles; University of California, Davis; Children's Hospital Los Angeles) and outside California (Children's National Medical Center, Children's Hospital Colorado, St. Jude Children's Research Hospital) for mNGS testing, and evaluate the impact on the assay on diagnostic yield, hospital costs and clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
214
This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
University of California, Davis Medical Center
Davis, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
University of California, Los Angeles Medical Center
Los Angeles, California, United States
University of California, San Francisco Medical Center
Total Number of Cases With at Least One Provider Response
Investigators will evaluate impact of mNGS assay by clinician surveys and Clinical Microbial Sequencing Board (CMSB) feedback and discussion as measured by at least 1 provider response per case.
Time frame: within 1 month of patient enrollment in study
Clinical Outcomes: Time From Cerebrospinal Fluid Collection to mNGS Results
Investigators will review medical records to determine time of initial presentation and measure the time to mNGS results.
Time frame: from admission to 1 month post discharge for each patient during the enrollment period of study
Clinical Outcomes: Length of Stay
Investigators will review medical records to determine length of stay including discharge to rehab facilities.
Time frame: from admission to 1 month post discharge for each patient during the enrollment period of study
Clinical Outcomes: Final Diagnosis Category
Investigators will review medical records to determine final diagnosis after all diagnostic testing has been performed including metagenomic Next-Gen sequencing and autopsy where applicable.
Time frame: from admission to time of final case review (1 month post discharge or up to one year)
Clinical Outcomes: Concordance of mNGS With Other Molecular Testing on Cerebrospinal Fluid Pathogens
mNGS findings were compared to conventional testing for concordance. Conventional testing included both tests that were ordered as part of each patients workup and those order to confirm mNGS findings on cerebrospinal fluid (CSF).
Time frame: from admission to 1 month post discharge for each patient during the enrollment period of study
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San Francisco, California, United States
Children's Hospital Colordao
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
St. Jude Children's Research Hospital
Nashville, Tennessee, United States