- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864903
A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
May 14, 2017 updated by: Shaare Zedek Medical Center
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.
Study Overview
Status
Withdrawn
Conditions
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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Ness Ziona, Israel, 74036
- MND Diagnostics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- any child undergoing a spinal tap
- parents agreed on participation
Exclusion Criteria:
- refusal to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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pediatric ER
any child undergoing a spinal tap due to suspected meningitis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yechiel Schlesinger, MD, Shaare Zedek Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
March 18, 2009
First Submitted That Met QC Criteria
March 18, 2009
First Posted (Estimate)
March 19, 2009
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 14, 2017
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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