Clinical Trials Logo
  1. Home
  2. Infection
  3. NCT03796546

Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF — PIPSEC  

Infection Clinical Trial

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03796546
Study type Observational
Source IDbyDNA, Inc.
Contact
Status Completed
Phase
Start date January 22, 2019
Completion date October 7, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT04529421 - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting NCT00342589 - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Withdrawn NCT04217252 - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Withdrawn NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting NCT02768454 - Antimicrobials Stewardship by Pharmacist N/A
Completed NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery N/A
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Recruiting NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts N/A
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Completed NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Terminated NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants Phase 1
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A