Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

NCT03796546 | Completed

• 1 other identifier: PIPSEC - 01
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 3

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.

Conditions

Infection; Meningitis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Utilization

  24 months

Other Outcomes (3)

• Post-Hoc Analysis - Economic Evaluation (1)

  24 months

• Post-Hoc Analysis - Economic Evaluation (2)

  24 months

• Post-Hoc Analysis - Host Response

  24 months

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• mL of appropriately stored CSF is available following completion of all standard of care testing

You may not qualify if:

• CSF Red blood cell (RBC) count \> 5000 cells/µL on same CSF sample as with pleocytosis
• Unable to obtain consent

Sponsors & Collaborators

• IDbyDNA, Inc.: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (3)

CHOC Children's Hospital Orange County

Orange, California, 92868, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual cerebrospinal fluid collected for standard of care clinical diagnostic purposes

MeSH Terms

Conditions

Infections; Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 8, 2019
• Study Start: January 22, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

US (3)