Study Stopped
The enzymatic assay was not sensitive nor spesific for the test.
A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection
1 other identifier
observational
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2009
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 16, 2017
March 1, 2009
6 months
March 18, 2009
May 14, 2017
Conditions
Keywords
Study Arms (1)
pediatric ER
any child undergoing a spinal tap due to suspected meningitis
Eligibility Criteria
children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
You may qualify if:
- any child undergoing a spinal tap
- parents agreed on participation
You may not qualify if:
- refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
MND Diagnostics
Ness Ziona, 74036, Israel
Biospecimen
Cerebrospinal Fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yechiel Schlesinger, MD
Shaare Zedek Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 19, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
May 16, 2017
Record last verified: 2009-03