Status:
COMPLETED
Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
Lead Sponsor:
IDbyDNA, Inc.
Collaborating Sponsors:
Rady Children's Hospital, San Diego
Conditions:
Infection
Meningitis
Eligibility:
All Genders
Up to 17 years
Brief Summary
Prospective, multi-site, study to evaluate the diagnosis rate of DNA and RNA sequencing of cerebrospinal fluid for identification of pathogens directly in patients who have already had a spinal tap to...
Detailed Description
IDbyDNA, Inc. has developed a robust sequencing reference database for viruses, bacteria, fungi and parasites and developed novel analysis methods to analyze next-generation (NGS) sequencing data to r...
Eligibility Criteria
Inclusion
- Age 0-17 years of age (not yet 18)
- Clinical evaluation for CNS infection
- CSF white blood cell count (WBC) \> 15 cells/µL when there are less than 5000 RBCs on same
- Admitted to a participating study site
- CSF obtained per standard protocol
- 1 mL of appropriately stored CSF is available following completion of all standard of care testing
Exclusion
- CSF Red blood cell (RBC) count \> 5000 cells/µL on same CSF sample as with pleocytosis
- Unable to obtain consent
Key Trial Info
Start Date :
January 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03796546
Start Date
January 22 2019
End Date
October 7 2020
Last Update
November 10 2020
Active Locations (3)
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1
CHOC Children's Hospital Orange County
Orange, California, United States, 92868
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
Nicklaus Children's Hospital
Miami, Florida, United States, 33155