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| Sponsors and Collaborators: |
Shaare Zedek Medical Center MDS Diagnostics |
|---|---|
| Information provided by: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00864903 |
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: | Case-Only, Prospective |
| Official Title: | A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection |
Cerebrospinal Fluid
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
pediatric ER
any child undergoing a spinal tap due to suspected meningitis
|
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 |
children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yechiel Schlesinger, MD | 972-2-666-6340 | yechiel@szmc.org.il |
| Contact: Ehud Even-Or, MD | 972-2-6417095 | udi.evenor@gmail.com |
| Israel | |
| Shaare Zedek Medical Center | |
| Jerusalem, Israel, 91031 | |
| MND Diagnostics | |
| Ness Ziona, Israel, 74036 | |
| Principal Investigator: | Yechiel Schlesinger, MD | Shaare Zedek Medical Center |
More Information
| Responsible Party: | Shaare Zedek Medical Center ( Dr. Yechiel Schlesinger, MD / Head of Infectious Diseases Unit ) |
| Study ID Numbers: | SZMC |
| Study First Received: | March 18, 2009 |
| Last Updated: | March 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00864903 History of Changes |
| Health Authority: | Israel: Ethics Commission |
|
enterovirus aseptic meningitis real time PCR diagnostics |
|
Virus Diseases Central Nervous System Infections Meningitis, Viral Central Nervous System Diseases |
Picornaviridae Infections Enterovirus Infections Meningitis |
|
Virus Diseases RNA Virus Infections Central Nervous System Infections Meningitis, Viral Nervous System Diseases |
Central Nervous System Diseases Picornaviridae Infections Central Nervous System Viral Diseases Enterovirus Infections Meningitis |
