Clinical trial NCT03796546: Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Meningitis
Keywords: Pediatric
Lead sponsor: IDbyDNA, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rady Children's Hospital, San Diego
First posted: 2019-01-08
Enrollment: 71
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This project will enroll children who are having an evaluation for central nervous system (CNS) infection and have already had a lumbar puncture to obtain cerebrospinal fluid (CSF) to evaluate for infection and host immune response. As such enrolled patients will be undergoing an evaluation for suspected meningitis, encephalitis, ventriculitis and VP shunt infection.

Patients in whom there is CSF remaining after standard testing has been obtained and who meet the other inclusion criteria will be approached for enrollment in the study.

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Rate
timeFrame: 24 months
Secondary outcomes:
measure: Clinical Utilization
timeFrame: 24 months
Other outcomes:
measure: Post-Hoc Analysis - Economic Evaluation (1)
timeFrame: 24 months
measure: Post-Hoc Analysis - Economic Evaluation (2)
timeFrame: 24 months
measure: Post-Hoc Analysis - Host Response
timeFrame: 24 months
Locations:
city: Orange
country: United States
facility: CHOC Children's Hospital Orange County
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
Study officials:
References: