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Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

NCT ID: NCT03796546

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2020-10-07

Brief Summary

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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

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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.

Conditions

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Infection Meningitis

Keywords

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Pediatric

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rady Children's Hospital, San Diego

OTHER

Sponsor Role collaborator

IDbyDNA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHOC Children's Hospital Orange County

Orange, California, United States

Site Status

Rady Children's Hospital

San Diego, California, United States

Site Status

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PIPSEC - 01

Identifier Type: -

Identifier Source: org_study_id