N/A
N=214
Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort
Encephalitis · Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT02910037 ↗Enrolled (actual)
214
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Total Number of Cases With at Least One Provider Response — 98; 58 cases
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mNGS for pathogen detection (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Cases With at Least One Provider Response |
98; 58 | — |
| SECONDARY Clinical Outcomes: Time From Cerebrospinal Fluid Collection to mNGS Results |
13.5 | — |
| SECONDARY Clinical Outcomes: Length of Stay |
27.9 | — |
| SECONDARY Clinical Outcomes: Final Diagnosis Category |
17; 57; 7; 3; 3; 0 | — |
| SECONDARY Clinical Outcomes: Concordance of mNGS With Other Molecular Testing on Cerebrospinal Fluid Pathogens |
16; 174; 9; 1; 4 | — |
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.
Eligibility Criteria
Exclusions:
- Patients on a 5150 or 5250 psychiatric hold
- Prisoners
- University of California employees / students or close associates of any of the key personnel on the study
- Outpatients and/or patients with chronic illness
Inclusion:
Demographic Criteria
- Age: any (no age limit)
- Language: any (with the use of interpreting services for obtaining consent)
For the following, the infectious syndromes include meningitis, encephalitis, fever, sepsis, and pneumonia:
Clinical Criteria
- Hospital admission or transfer with diagnosis of an presumed infectious syndrome or clinical presentation consisting with an infectious syndrome, as defined below:
- Meningitis: fever >38°C and abnormal imaging or CSF pleocytosis (CSF white blood cell count (WBC) > 5 /mm^3) +/- stiff neck, +/- headache, +/- seizure
- Encephalitis: pleocytosis and at least one of the following: altered mental status, seizures, new onset of focal neurologic findings, abnormal EEG, acute brain abnormalities on neuroimaging
- No known diagnosis of non-infectious etiology responsible for symptoms
- Time of enrollment: within 7 days of onset of symptoms, either initial presentation or acute exacerbation of presumed infectious syndrome.
Specimen Criteria
- cerebrospinal fluid available within 7 days of symptom onset AND within 3 days of hospital admission or transfer unless evidence for acute exacerbation as defined by abrupt decline in clinical status, worsening pleocytosis or other laboratory parameters
- Minimum of 600 microliters (uL) of clinical sample, stored at 4 degrees Celsius (C) no more than 5 days (ideally frozen in -70 degrees Celsius within 24 hours of collection)
- No more than 3 freeze-thaw cycles
Data sourced from ClinicalTrials.gov (NCT02910037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.