CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 214 enrolled
Drug / intervention
mNGS for pathogen detectiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02910037
NCT02910037N/ACompleted
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Clinical Implementation of Metagenomic Next-Generation Sequencing for Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort

University of California, San Francisco·interventional·Posted Sep 21, 2016·Updated May 27, 2021

In Brief

A clinical study evaluating mNGS for pathogen detection for Encephalitis and Meningitis. Completed, enrolled 214 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis, Meningitis
CountriesUnited States
CollaboratorsCalifornia Initiative to Advance Precision Medicine, Sandler Foundation, Bowes Foundation, Charles and Helen Schwab Foundation, University of California, Davis, University of California, Los Angeles, Children's Hospital Los Angeles, Children's Hospital Colorado, St. Jude Children's Research Hospital, Children's National Research Institute, University of California, Berkeley, DNAnexus, Inc., Syapse, Inc.

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartJun 1, 2016
Primary CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.8 years ago

Interventions

mNGS for pathogen detectiondevice

This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.