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Trial record 53 of 463 for:    shaare zedek

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

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. Identifier: NCT00864903
Recruitment Status : Withdrawn (The enzymatic assay was not sensitive nor spesific for the test.)
First Posted : March 19, 2009
Last Update Posted : May 16, 2017
Information provided by:
Shaare Zedek Medical Center

Brief 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.

Condition or disease
Viral 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.

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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

pediatric ER
any child undergoing a spinal tap due to suspected meningitis

Biospecimen Retention:   Samples With DNA
Cerebrospinal Fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to participate in the study

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 identifier (NCT number): NCT00864903

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Shaare Zedek Medical Center
Jerusalem, Israel, 91031
MND Diagnostics
Ness Ziona, Israel, 74036
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Yechiel Schlesinger, MD Shaare Zedek Medical Center
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Responsible Party: Dr. Yechiel Schlesinger, MD / Head of Infectious Diseases Unit, Shaare Zedek Medical Center Identifier: NCT00864903    
Other Study ID Numbers: SZMC
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: March 2009
Keywords provided by Shaare Zedek Medical Center:
aseptic meningitis
real time PCR
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Viral
Enterovirus Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Picornaviridae Infections
RNA Virus Infections