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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Shaare Zedek Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
MDS Diagnostics
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00864903
First received: March 18, 2009
Last updated: September 17, 2009
Last verified: March 2009
History of Changes

March 18, 2009
September 17, 2009
April 2009
October 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00864903 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cerebrospinal Fluid
Non-Probability Sample

children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
Viral Meningitis
Not Provided
pediatric ER
any child undergoing a spinal tap due to suspected meningitis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
November 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • any child undergoing a spinal tap
  • parents agreed on participation

Exclusion Criteria:

  • refusal to participate in the study
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00864903
SZMC
No
Dr. Yechiel Schlesinger, MD / Head of Infectious Diseases Unit, Shaare Zedek Medical Center
Shaare Zedek Medical Center
MDS Diagnostics
Principal Investigator: Yechiel Schlesinger, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP