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
  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


Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: November 2009
Estimated 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

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864903

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

No publications provided

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
Study First Received: March 18, 2009
Last Updated: September 17, 2009
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 17, 2014