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

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00864903
Collaborator
(none)
0
Enrollment
2
Locations
7
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Apr 1, 2009
    Actual Primary Completion Date :
    Oct 1, 2009
    Actual Study Completion Date :
    Nov 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    pediatric ER

    any child undergoing a spinal tap due to suspected meningitis

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 16 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • any child undergoing a spinal tap

      • parents agreed on participation

      Exclusion Criteria:
      • refusal to participate in the study

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Shaare Zedek Medical Center Jerusalem Israel 91031
      2 MND Diagnostics Ness Ziona Israel 74036

      Sponsors and Collaborators

      • Shaare Zedek Medical Center

      Investigators

      • Principal Investigator: Yechiel Schlesinger, MD, Shaare Zedek Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00864903
      Other Study ID Numbers:
      • SZMC
      First Posted:
      Mar 19, 2009
      Last Update Posted:
      May 16, 2017
      Last Verified:
      Mar 1, 2009
      Keywords provided by , ,
      enterovirus
      aseptic meningitis
      real time PCR
      diagnostics
      Additional relevant MeSH terms:
      Meningitis, Viral
      Enterovirus Infections
      Meningitis

      Study Results

      No Results Posted as of May 16, 2017