Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 3/2/2019 |
| Start Date: | January 22, 2019 |
| End Date: | January 1, 2022 |
A Prospective Trial to Investigate the Clinical Utility and Application of a Next Generation Sequencing Test for Pathogen Detection of Cerebral Spinal Fluid (CSF) Samples to Diagnose Pediatric Central Nervous System (CNS) Infections
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 evaluate for infection and were found to have a pleocytosis. Diagnostic rate
and clinical utility of concurrent standard testing will be compared to diagnostic rate and
clinical utility of DNA and RNA sequencing.
cerebrospinal fluid for identification of pathogens directly in patients who have already had
a spinal tap to evaluate for infection and were found to have a pleocytosis. Diagnostic rate
and clinical utility of concurrent standard testing will be compared to diagnostic rate and
clinical utility of DNA and RNA sequencing.
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 rapidly identify infectious agents. This technology suite, known as the
Explify™ platform, holds the promise to improve patient care and efficiently guide provider
treatment planning for those suffering from infectious disease.
The PIPSEC trial, developed by pediatric physicians specializing in genomic medicine, is
intended to facilitate the acquisition of high quality and clinically annotated biospecimens
for the purpose of research discovery. This project intends to advance metagenomics,
microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing
cerebral spinal fluid (CSF) specimens to contribute to the diagnosis of infectious agents
impacting the central nervous system among pediatric patients. Clinically annotated specimens
will facilitate continued development and validation of the Explify test and its clinical
utility for providers treating central nervous system (CNS) infections.
The primary objective is to assess clinical utility of the Explify test compared to
concurrent standard of care testing to identify pathogens from CSF fluid within a pediatric
patient population.
fungi and parasites and developed novel analysis methods to analyze next-generation (NGS)
sequencing data to rapidly identify infectious agents. This technology suite, known as the
Explify™ platform, holds the promise to improve patient care and efficiently guide provider
treatment planning for those suffering from infectious disease.
The PIPSEC trial, developed by pediatric physicians specializing in genomic medicine, is
intended to facilitate the acquisition of high quality and clinically annotated biospecimens
for the purpose of research discovery. This project intends to advance metagenomics,
microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing
cerebral spinal fluid (CSF) specimens to contribute to the diagnosis of infectious agents
impacting the central nervous system among pediatric patients. Clinically annotated specimens
will facilitate continued development and validation of the Explify test and its clinical
utility for providers treating central nervous system (CNS) infections.
The primary objective is to assess clinical utility of the Explify test compared to
concurrent standard of care testing to identify pathogens from CSF fluid within a pediatric
patient population.
Inclusion Criteria:
- 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 Criteria:
- CSF Red blood cell (RBC) count > 5000 cells/µL on same CSF sample as with pleocytosis
- Unable to obtain consent
We found this trial at
2
sites
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