Trial Outcomes & Findings for Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort (NCT NCT02910037)
NCT ID: NCT02910037
Last Updated: 2021-05-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
214 participants
Primary outcome timeframe
within 1 month of patient enrollment in study
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
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).
mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
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|---|---|
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Overall Study
STARTED
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214
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Overall Study
COMPLETED
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204
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
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).
mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Lost to Follow-up
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6
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Baseline Characteristics
Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort
Baseline characteristics by cohort
| Measure |
Patients Enrolled for mNGS Testing
n=204 Participants
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).
mNGS for pathogen detection: This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
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|---|---|
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Age, Categorical
<=18 years
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45 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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124 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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35 Participants
n=5 Participants
|
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Age, Continuous
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39.6 years
STANDARD_DEVIATION 22.5 • n=5 Participants
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Sex: Female, Male
Female
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90 Participants
n=5 Participants
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Sex: Female, Male
Male
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114 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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17 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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42 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
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Region of Enrollment
United States
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204 participants
n=5 Participants
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PRIMARY outcome
Timeframe: within 1 month of patient enrollment in studyPopulation: Treating teams for 204 included patients
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.
Outcome measures
| Measure |
Pre mNGS Result Feedback From Providers
n=204 Participants
Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
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Post mNGS Results Feedback From Providers
n=204 Participants
Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
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Neoplastic
Patients that received a definitive neoplastic diagnosis for their CNS disease.
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Post Infectious
Patients that received a definitive post infectious diagnosis for their CNS disease.
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Toxic Metabolic
Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
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Structural
Patients that received a definitive structural diagnosis for their CNS disease.
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Vascular
Patients that received a definitive vascular diagnosis for their CNS disease.
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Other
Patients that received a definitive diagnosis for their CNS disease in another category.
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Unknown
Patients that did not received a definitive diagnosis for their CNS disease.
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|---|---|---|---|---|---|---|---|---|---|
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Total Number of Cases With at Least One Provider Response
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98 cases
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58 cases
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: from admission to 1 month post discharge for each patient during the enrollment period of studyInvestigators will review medical records to determine time of initial presentation and measure the time to mNGS results.
Outcome measures
| Measure |
Pre mNGS Result Feedback From Providers
n=204 Participants
Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
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Post mNGS Results Feedback From Providers
Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
|
Neoplastic
Patients that received a definitive neoplastic diagnosis for their CNS disease.
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Post Infectious
Patients that received a definitive post infectious diagnosis for their CNS disease.
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Toxic Metabolic
Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
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Structural
Patients that received a definitive structural diagnosis for their CNS disease.
|
Vascular
Patients that received a definitive vascular diagnosis for their CNS disease.
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Other
Patients that received a definitive diagnosis for their CNS disease in another category.
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Unknown
Patients that did not received a definitive diagnosis for their CNS disease.
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|---|---|---|---|---|---|---|---|---|---|
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Clinical Outcomes: Time From Cerebrospinal Fluid Collection to mNGS Results
|
13.5 days
Standard Deviation 4.8
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: from admission to 1 month post discharge for each patient during the enrollment period of studyInvestigators will review medical records to determine length of stay including discharge to rehab facilities.
Outcome measures
| Measure |
Pre mNGS Result Feedback From Providers
n=204 Participants
Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
|
Post mNGS Results Feedback From Providers
Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
|
Neoplastic
Patients that received a definitive neoplastic diagnosis for their CNS disease.
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Post Infectious
Patients that received a definitive post infectious diagnosis for their CNS disease.
|
Toxic Metabolic
Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
|
Structural
Patients that received a definitive structural diagnosis for their CNS disease.
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Vascular
Patients that received a definitive vascular diagnosis for their CNS disease.
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Other
Patients that received a definitive diagnosis for their CNS disease in another category.
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Unknown
Patients that did not received a definitive diagnosis for their CNS disease.
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|---|---|---|---|---|---|---|---|---|---|
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Clinical Outcomes: Length of Stay
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27.9 days
Standard Deviation 32.5
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pre mNGS Result Feedback From Providers
n=204 Participants
Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
|
Post mNGS Results Feedback From Providers
n=204 Participants
Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
|
Neoplastic
n=204 Participants
Patients that received a definitive neoplastic diagnosis for their CNS disease.
|
Post Infectious
n=204 Participants
Patients that received a definitive post infectious diagnosis for their CNS disease.
|
Toxic Metabolic
n=204 Participants
Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
|
Structural
n=204 Participants
Patients that received a definitive structural diagnosis for their CNS disease.
|
Vascular
n=204 Participants
Patients that received a definitive vascular diagnosis for their CNS disease.
|
Other
n=204 Participants
Patients that received a definitive diagnosis for their CNS disease in another category.
|
Unknown
n=204 Participants
Patients that did not received a definitive diagnosis for their CNS disease.
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|---|---|---|---|---|---|---|---|---|---|
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Clinical Outcomes: Final Diagnosis Category
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17 Participants
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57 Participants
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7 Participants
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3 Participants
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3 Participants
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0 Participants
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1 Participants
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15 Participants
|
101 Participants
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SECONDARY outcome
Timeframe: from admission to 1 month post discharge for each patient during the enrollment period of studymNGS 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).
Outcome measures
| Measure |
Pre mNGS Result Feedback From Providers
n=204 Participants
Response from treating clinicians regarding differential for patients before mNGS for pathogen detection was resulted.
|
Post mNGS Results Feedback From Providers
n=204 Participants
Response for survey from treating clinicians regarding differential and impact of mNGS results on care.
|
Neoplastic
n=204 Participants
Patients that received a definitive neoplastic diagnosis for their CNS disease.
|
Post Infectious
n=204 Participants
Patients that received a definitive post infectious diagnosis for their CNS disease.
|
Toxic Metabolic
n=204 Participants
Patients that received a definitive toxic metabolic diagnosis for their CNS disease.
|
Structural
Patients that received a definitive structural diagnosis for their CNS disease.
|
Vascular
Patients that received a definitive vascular diagnosis for their CNS disease.
|
Other
Patients that received a definitive diagnosis for their CNS disease in another category.
|
Unknown
Patients that did not received a definitive diagnosis for their CNS disease.
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|---|---|---|---|---|---|---|---|---|---|
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Clinical Outcomes: Concordance of mNGS With Other Molecular Testing on Cerebrospinal Fluid Pathogens
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16 Participants
|
174 Participants
|
9 Participants
|
1 Participants
|
4 Participants
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—
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—
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Adverse Events
Patients Enrolled for mNGS Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charles Chiu
The University of California, San Francisco
Phone: (415) 514-8219
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place