Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort (PDAID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02910037|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Encephalitis Meningitis||Device: mNGS for pathogen detection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Implementation of Metagenomic Next-Generation Sequencing for Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
Experimental: patients enrolled for mNGS testing
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).
Device: mNGS for pathogen detection
This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
- Impact on clinical reasoning and management [ Time Frame: 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
- Cost of care for patients hospitalized for encephalitis/meningitis [ Time Frame: from admission to 1 month post discharge for each patient during the enrollment period of study (ends June 2017) ]Two data sets will be used during the duration of this study. Claims data will be used to analyze 5 years of retrospective cost data on patients hospitalized with encephalitis and/or meningitis. This data set will be used to establish a reference for total cost of care, average length of stay and number of invasive procedures. Statistical models will be proposed to evaluate the cost-effectiveness based on time of intervention of the mNGS assay for pathogen detection (i.e. at presentation in emergency department, at time of repeat lumbar puncture, or based on hospital location - Emergency Department to Intensive Care Unit). Patients enrolled in this research study will also be consented to sharing billing data with the investigators. This will be evaluated and compared to the retrospective claims data.
- Clinical outcomes: time to diagnosis [ Time Frame: from admission to 1 month post discharge for each patient during the enrollment period of study (ends June 2017) ]Investigators will review medical records to determine time to definitive diagnosis for patients enrolled in the study.
- Clinical outcomes: length of stay [ Time Frame: from admission to 1 month post discharge for each patient during the enrollment period of study (ends June 2017) ]Investigators will review medical records to determine length of stay including discharge to rehab facilities.
- Clinical outcomes: treatments given and time to targeted therapy [ Time Frame: from admission to 1 month post discharge for each patient during the enrollment period of study (ends June 2017) ]Investigators will review medical records and discuss with treatment teams to determine therapies given and treatment strategy to measure time to targeted therapy.
- Clinical outcomes: number of diagnostic tests and invasive procedures [ Time Frame: from admission to 1 month post discharge for each patient during the enrollment period of study (ends June 2017) ]Investigators will review medical records and discuss with treatment teams to track the number of diagnostic tests send and invasive procedures performed before definitive diagnosis established for patients enrolled in study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910037
|United States, California|
|University of California, Davis Medical Center|
|Davis, California, United States, 95616|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|University of California, Los Angeles Medical Center|
|Los Angeles, California, United States, 90095|
|University of California, San Francisco Medical Center|
|San Francisco, California, United States, 94116|
|United States, Colorado|
|Children's Hospital Colordao|
|Denver, Colorado, United States, 80045|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Charles Y Chiu, MD, PhD||University of California, San Francisco|
|Study Director:||Hannah Sample, BS||University of California, San Francisco|