A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection

Viral Meningitis Clinical Trial

Official title:

A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00864903
• Other study ID #: SZMC
• Status: Withdrawn
• Phase: N/A
• First received: March 18, 2009
• Last updated: May 14, 2017
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2009
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• any child undergoing a spinal tap

• parents agreed on participation

Exclusion Criteria:

• refusal to participate in the study

Related Conditions & MeSH terms

• Enterovirus Infections
• Meningitis
• Viral Meningitis

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	MND Diagnostics	Ness Ziona

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel,