Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

Completed

Conditions studied: Infection, Meningitis

In brief

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.

Key facts

Study ID

NCT03796546

Run by

IDbyDNA, Inc.

People needed

71

Starts

2019-01-22

Expected to finish

2020-10-07

Last updated by the study team

2020-11-10

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

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
• 1 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

Where it is running

• CHOC Children's Hospital Orange County — Orange, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Nicklaus Children's Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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