Overview

This trial is active, not recruiting.

Condition viral meningitis
Sponsor Shaare Zedek Medical Center
Collaborator MDS Diagnostics
Start date April 2009
End date October 2009
Trial size 200 participants
Trial identifier NCT00864903, SZMC

Summary

A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
any child undergoing a spinal tap due to suspected meningitis

Eligibility Criteria

Male or female participants up to 16 years old.

Inclusion Criteria: - any child undergoing a spinal tap - parents agreed on participation Exclusion Criteria: - refusal to participate in the study

Additional Information

Official title A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection
Principal investigator Yechiel Schlesinger, MD
Description MND's new enzymatic assay is based on the detection of a specific viral enzyme through the detection of its enzymatic reaction. The detection of a specific enzymatic reaction is indicative to the presence of the specific virus in a biological specimen. This study will compare this diagnostic assay to RT-PCR for diagnosis of enteroviral infection in cerebrospinal fluid. CSF samples will be taken from children undergoing a spinal tap at the pediatric ER due to a suspicion of meningitis. A total of 100 samples will be collected, from children 0-16 years old who's parents agreed on participation in the study. A comparison of the enzymatic assay to RT-PCR as well as calibration and validation of the new assay will be done with the harvested samples, for a rapid and accurate identification of Enterovirus in human cerebrospinal fluid.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Shaare Zedek Medical Center.