MeningoencephalitisNCT02207647
Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients
An observational study of Meningoencephalitis and Other Syndromes Requiring Lumbar Puncture in Emergency Department, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
Trial summary
Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Meningoencephalitis, Other Syndromes Requiring Lumbar Puncture in Emergency Department
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2021
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted by the Emergency ID Net Study group (P.I. David Talan), which consists of a network of 10 emergency departments in university-affiliated hospitals throughout the United States.
Who may be able to join
- Age > or = 3 months old
- Receiving a Lumbar Puncture in the emergency department as part of their standard care.
Who cannot join
- No CSF available
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Progress in diagnostic technologies, especially molecular techniques based on genetic characteristics of potential pathogens, has greatly expanded the investigators capacity to evaluate specimens from patients for a much wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative agents for the approximately 50% of all such presentations which go un-diagnosed. The investigators propose a study involving a collaboration between the EMERGEncy ID NET, a network of 10 geographically diverse university-affiliated urban emergency departments (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and Prevention (CDC), to use these new technologies to address this issue.
- Being tested
- no intervention
- Medical subject headings
- Meningoencephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with syndromes requiring lumbar puncture | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of pathogens
We will describe the range and proportion of pathogens found in CSF among patients enrolled over a 2 year period.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016
- Study completionDec 2021
Why it stopped: Funding used up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningoencephalitisStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, David A. Talan, Olive View-UCLA Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207647
- Sponsor's protocol ID
- 12H-770352
- Other IDs
- U01CK000176
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2014
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients
- ClinicalTrials.gov ID
- NCT02207647
- Acronym / sponsor ID
- 12H-770352
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding used up
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 4 Aug 2014 (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.
Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Progress in diagnostic technologies, especially molecular techniques based on genetic characteristics of potential pathogens, has greatly expanded the investigators capacity to evaluate specimens from patients for a much wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative agents for the approximately 50% of all such presentations which go un-diagnosed. The investigators propose a study involving a collaboration between the EMERGEncy ID NET, a network of 10 geographically diverse university-affiliated urban emergency departments (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and Prevention (CDC), to use these new technologies to address this issue.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with syndromes requiring lumbar puncture | – | Other: no intervention |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted by the Emergency ID Net Study group (P.I. David Talan), which consists of a network of 10 emergency departments in university-affiliated hospitals throughout the United States.
Key inclusion criteria (2 listed)
- Age > or = 3 months old
- Receiving a Lumbar Puncture in the emergency department as part of their standard care.
Key exclusion criteria (1 listed)
- No CSF available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Patients with syndromes requiring lumbar puncture |
Primary outcome
prevalence of pathogens
Time frame: 2 years
We will describe the range and proportion of pathogens found in CSF among patients enrolled over a 2 year period.
Results and safety
The study was stopped early (reason given: Funding used up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningoencephalitis and Other Syndromes Requiring Lumbar Puncture in Emergency Department, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
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: stopped early, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 stopped early (reason given: Funding used up). Results are not available in the source record.
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.
What does the primary outcome measure?
prevalence of pathogens (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 20 Apr 2022.