Viral MeningitisNCT00864903
A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
An observational study of Viral Meningitis, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Viral Meningitis
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
Who may be able to join
- any child undergoing a spinal tap
- parents agreed on participation
Who cannot join
- refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 91031
MND Diagnostics
Ness Ziona, 74036
About this study
Official title: 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.
Read the 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.
- Conditions
- Viral Meningitis
- Keywords
- enterovirus, aseptic meningitis, real time PCR, diagnostics
- Medical subject headings
- Meningitis, Viral, Enterovirus Infections, Meningitis, Aseptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric ER | any child undergoing a spinal tap due to suspected meningitis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionNov 2009
Why it stopped: The enzymatic assay was not sensitive nor spesific for the test.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yechiel Schlesinger, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864903
- Sponsor's protocol ID
- SZMC
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection
- ClinicalTrials.gov ID
- NCT00864903
- Acronym / sponsor ID
- SZMC
- Conditions
- Viral Meningitis
- Keywords
- enterovirus, aseptic meningitis, real time PCR, diagnostics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The enzymatic assay was not sensitive nor spesific for the test.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric ER | – | –any child undergoing a spinal tap due to suspected meningitis |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children age 0-16 years who undergo a spinal tap at the pediatric ER due to suspected meningitis.
Key inclusion criteria (2 listed)
- any child undergoing a spinal tap
- parents agreed on participation
Key exclusion criteria (1 listed)
- refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yechiel Schlesinger, MD principal investigator
Shaare Zedek Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Meningitis, run by Shaare Zedek Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.