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

This study has been withdrawn prior to enrollment.
(The enzymatic assay was not sensitive nor spesific for the test.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864903
First Posted: March 19, 2009
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose
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.

Condition
Viral Meningitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Biospecimen Retention:   Samples With DNA
Cerebrospinal Fluid

Enrollment: 0
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
pediatric ER
any child undergoing a spinal tap due to suspected meningitis

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864903


Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
MND Diagnostics
Ness Ziona, Israel, 74036
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yechiel Schlesinger, MD Shaare Zedek Medical Center
  More Information

Responsible Party: Dr. Yechiel Schlesinger, MD / Head of Infectious Diseases Unit, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00864903     History of Changes
Other Study ID Numbers: SZMC
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: May 16, 2017
Last Verified: March 2009

Keywords provided by Shaare Zedek Medical Center:
enterovirus
aseptic meningitis
real time PCR
diagnostics

Additional relevant MeSH terms:
Meningitis
Enterovirus Infections
Meningitis, Viral
Central Nervous System Diseases
Nervous System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Viral Diseases
Central Nervous System Infections