Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

Infection Clinical Trial

— PIPSEC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796546
• Other study ID #: PIPSEC - 01
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: October 7, 2020

Study information

• Verified date: November 2020
• Source: IDbyDNA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Meningitis

Locations

Country	Name	City	State
United States	Nicklaus Children's Hospital	Miami	Florida
United States	CHOC Children's Hospital Orange County	Orange	California
United States	Rady Children's Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
IDbyDNA, Inc.	Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-Hoc Analysis - Economic Evaluation (1)	Economic evaluation of cost of standard of care testing compared to economic cost of NGS testing: Determination of what diagnosis made could have been made with best possible clinical tests currently available.	24 months
Other	Post-Hoc Analysis - Economic Evaluation (2)	Cost analysis of what best available testing would have cost.	24 months
Other	Post-Hoc Analysis - Host Response	RNA sequencing to determine if there is a specific host response to either specific infectious or noninfectious etiologies.	24 months
Primary	Diagnostic Rate	Comparison of the sensitivity, specificity, positive and negative predictive values of IDbyDNA NGS results with the Explify diagnostic platform compared with standard care.	24 months
Secondary	Clinical Utilization	Change of Management resulting from NGS diagnosis versus diagnosis based on standard of care. Change of Management is a binary (yes or no) based on assignments made by the PI or designee at each site using the following domains: Diagnosis specific pharmacological treatment; Diagnosis specific management; Diagnosis specific supportive interventions A change in any of these domains will be considered a change of clinical management for utilization purposes.	24 months

External Links

•   Sponsor Website