Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort

Not Applicable

Completed

• Conditions: Encephalitis; Meningitis
• Interventions: Device: mNGS for pathogen detection

• Registration Number: NCT02910037
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Results First Submitted: 2019-06-21
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Results First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients enrolled for mNGS testing	mNGS for pathogen detection	Patients with meningitis and/or encephalitis will be enrolled in this study in order to analyze the clinical utility of mNGS for pathogen detection. There is no control group for this study (Investigators will identify historical controls by retrospective chart review and clinical reimbursement documents).

Primary Outcome Measures

Name	Time	Method
Total Number of Cases With at Least One Provider Response	within 1 month of patient enrollment in study	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes: Time From Cerebrospinal Fluid Collection to mNGS Results	from admission to 1 month post discharge for each patient during the enrollment period of study	Investigators will review medical records to determine time of initial presentation and measure the time to mNGS results.
Clinical Outcomes: Length of Stay	from admission to 1 month post discharge for each patient during the enrollment period of study	Investigators will review medical records to determine length of stay including discharge to rehab facilities.
Clinical Outcomes: Final Diagnosis Category	from admission to time of final case review (1 month post discharge or up to one year)	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.
Clinical Outcomes: Concordance of mNGS With Other Molecular Testing on Cerebrospinal Fluid Pathogens	from admission to 1 month post discharge for each patient during the enrollment period of study	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).

Trial Locations

Locations (7)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

St. Jude Children's Research Hospital; 🇺🇸 Nashville, Tennessee, United States

University of California, Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

University of California, Davis Medical Center; 🇺🇸 Davis, California, United States

Children's Hospital Colordao; 🇺🇸 Denver, Colorado, United States